Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02466971
Other study ID # NCI-2015-00835
Secondary ID NCI-2015-00835NR
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date May 10, 2016
Est. completion date September 21, 2024

Study information

Verified date March 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.


Description:

PRIMARY OBJECTIVE: I. To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase overall survival relative to the standard/control regimen of cisplatin and radiation in women with uterine cervix or vaginal cancer. SECONDARY OBJECTIVE: I. To determine the relative progression-free survival impact of triapine-cisplatin radio-chemotherapy and cisplatin radio-chemotherapy. TERTIARY OBJECTIVES: I. To evaluate incidence and severity of hematologic and gastrointestinal (GI) adverse events by radiation modality; image guided intensity modulated radiation therapy (IG-IMRT) versus conventional pelvic radiotherapy. (05/30/2017) II. To summarize and compare differences in acute adverse events (Common Terminology Criteria for Adverse Events [CTCAE], version [v]4.0) by treatment arm and by radiation modality. (05/30/2017) III. To summarize and compare differences in chronic or late (>= 30-days from off study treatment date) adverse events (CTCAE, v4.0) by treatment arm and by radiation modality. (05/30/2017) IV. To determine peripheral blood methemoglobin proportion before and after triapine infusion (optional for Arm 2 patients). V. To explore whether knowledge-based planning (KBP) can improve IG-IMRT plans compared to plans that would have been delivered without KBP, estimate the resulting toxicity reduction using normal tissue complication probability (NTCP) models, and determine whether KBP should be a requirement for future IG-IMRT protocols. VI. To determine the post-therapy 3-month fludeoxyglucose F-18 (18F-FDG) PET/CT metabolic complete response rate by treatment arm VII. To compare acute toxicity and chemotherapy delivery for atlas-based IG-IMRT vs. positron emission tomography (PET)/computed tomography (CT)-based IG-IMRT vs. conventional radiation therapy (RT), and assess the impact of treatment on changes in hematopoietic compensatory response. VIII. To develop and validate machine learning and radiomics techniques for dose accumulation, automated treatment planning, and prediction of treatment response. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cisplatin intravenously (IV) over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo external beam radiation therapy (EBRT) (either conventional RT or intensity modulated radiation therapy [IMRT]) once daily (QD) 5 days a week for 25 fractions followed by low dose rate (LDR) or high dose rate (HDR) brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years, and then every 6 months for 3 years. The patient data from NCI #9434 will be merged with NRG-GY006 per the Protocol Analysis Plan.


Other known NCT identifiers
  • NCT01835171
  • NCT05358600

Recruitment information / eligibility

Status Active, not recruiting
Enrollment 450
Est. completion date September 21, 2024
Est. primary completion date January 26, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient has a new, unrated histologic diagnosis of stage IB2 (> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone; the presence or absence of para-aortic lymph node metastasis will be based on pre-therapy 18F-FDG PET/CT; NOTE: if the baseline 18F-FDG PET/CT identifies hypermetabolic para-aortic disease, such patients will NOT be eligible; the patient must be able to tolerate imaging requirements of an 18F-FDG PET/CT scan - Patient must provide study specific informed consent prior to study entry - Patient must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 or equivalent - Absolute neutrophil count > 1,500/uL - Platelets > 100,000/uL - Hemoglobin > 10 g/dL - Total bilirubin < 2.0 mg/dL - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal - Prothrombin time (PT)/activated partial thromboplastin time (aPTT) < 1.5 X institutional upper limit of normal - Creatinine =< 1.5 mg/dL to receive weekly cisplatin - Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if the estimated creatinine clearance (CCr) is >= 30 ml/min; for the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used - Patient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose > 200 mg/dL) - Patient has a life expectancy of greater than 20 weeks - Patient does not have known brain metastases (testing optional) - Patient does not have known human immunodeficiency virus syndrome (HIV, testing optional); known HIV-positive patients receiving combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with triapine - Patient does not have a known allergy to compounds of similar or biologic composition as triapine - Patient does not have known glucose-6-phosphate dehydrogenase (G6PD) deficiency as the condition interferes with triapine antidote metabolism (G6PD testing optional) - Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy) Exclusion Criteria: - Patient has another concurrent active invasive malignancy - Patient has had a prior invasive malignancy diagnosed within the last three years (except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix); patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician - Patient has uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within six months of protocol initiation, cardiac arrhythmia within six months of protocol initiation; known inadequately controlled hypertension; clinically significant pulmonary disease including dyspnea at rest, or patients requiring supplemental oxygen, or poor pulmonary reserve; or clinically significant renal function impairment (baseline serum creatinine > 2 mg/dL); or psychiatric illness/social situations that would limit compliance with study requirements - Patient is receiving another investigational agent for the treatment of cancer - Patient is currently pregnant - Patient does not agree to use two forms of birth control if they are of child-bearing potential - Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy following radiation as part of their cervical cancer treatment are ineligible (05/30/2017) - Patients scheduled to be treated with adjuvant consolidation chemotherapy or other anti-neoplastic therapy at the conclusion of their standard chemoradiation (05/30/2017) - Patients with self-reported or known diagnosis of G6PD deficiency (05/30/2017) - Patients with vaginal cancer may have previously undergone a hysterectomy for various indications; patients with vaginal cancer who underwent a hysterectomy for treatment of cervical cancer less than five years prior to their diagnosis of vaginal cancer are ineligible

Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Carcinoma
  • Carcinoma, Adenosquamous
  • Carcinoma, Squamous Cell
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Stage IB2 Cervical Cancer AJCC v6 and v7
  • Stage II Cervical Cancer AJCC v7
  • Stage II Vaginal Cancer AJCC v6 and v7
  • Stage IIA Cervical Cancer AJCC v7
  • Stage IIB Cervical Cancer AJCC v6 and v7
  • Stage III Vaginal Cancer AJCC v6 and v7
  • Stage IIIB Cervical Cancer AJCC v6 and v7
  • Stage IV Vaginal Cancer AJCC v6 and v7
  • Stage IVA Cervical Cancer AJCC v6 and v7
  • Stage IVA Vaginal Cancer AJCC v6 and v7
  • Unresectable Vaginal Carcinoma
  • Uterine Cervical Neoplasms
  • Vaginal Adenocarcinoma
  • Vaginal Adenosquamous Carcinoma
  • Vaginal Carcinoma
  • Vaginal Neoplasms
  • Vaginal Squamous Cell Carcinoma, Not Otherwise Specified

Intervention

Radiation:
Brachytherapy
Undergo brachytherapy
Drug:
Cisplatin
Given IV
Radiation:
External Beam Radiation Therapy
Undergo EBRT
Intensity-Modulated Radiation Therapy
Undergo IMRT
Other:
Laboratory Biomarker Analysis
Correlative studies
Radiation:
Radiation Therapy
Undergo conventional RT
Drug:
Triapine
Given IV

Locations

Country Name City State
Canada Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto Ontario
Puerto Rico Centro Comprensivo de Cancer de UPR San Juan
Puerto Rico San Juan City Hospital San Juan
Puerto Rico San Juan Community Oncology Group San Juan
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Jefferson Abington Hospital Abington Pennsylvania
United States Summa Health System - Akron Campus Akron Ohio
United States Saint Peter's Health Partners Albany New York
United States Women's Cancer Care Associates LLC Albany New York
United States Southwest Gynecologic Oncology Associates Inc Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States MultiCare Auburn Medical Center Auburn Washington
United States Augusta University Medical Center Augusta Georgia
United States UCHealth University of Colorado Hospital Aurora Colorado
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Greater Baltimore Medical Center Baltimore Maryland
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania
United States Overlake Medical Center Bellevue Washington
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Saint Charles Health System Bend Oregon
United States Walter Reed National Military Medical Center Bethesda Maryland
United States Billings Clinic Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States OSF Saint Joseph Medical Center Bloomington Illinois
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Maimonides Medical Center Brooklyn New York
United States Henry Ford Cancer Institute-Downriver Brownstown Michigan
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Roswell Park Cancer Institute Buffalo New York
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Highline Medical Center-Main Campus Burien Washington
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cooper Hospital University Medical Center Camden New Jersey
United States Aultman Health Foundation Canton Ohio
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Miami Valley Hospital South Centerville Ohio
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania
United States Geauga Hospital Chardon Ohio
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States Memorial Hospital Chattanooga Tennessee
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Mission Cancer and Blood - West Des Moines Clive Iowa
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Bay Area Hospital Coos Bay Oregon
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Dayton Physician LLC - Englewood Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Delaware Radiation Oncology Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Porter Adventist Hospital Denver Colorado
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Henry Ford Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Northeast Radiation Oncology Center Dunmore Pennsylvania
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Crossroads Cancer Center Effingham Illinois
United States Ephrata Cancer Center Ephrata Pennsylvania
United States Providence Regional Cancer Partnership Everett Washington
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Virginia Mason Federal Way Medical Center Federal Way Washington
United States Blanchard Valley Hospital Findlay Ohio
United States Parkview Hospital Randallia Fort Wayne Indiana
United States Parkview Regional Medical Center Fort Wayne Indiana
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Kaiser Permanente-Fremont Fremont California
United States Kaiser Permanente-Fresno Fresno California
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States University of Florida Health Science Center - Gainesville Gainesville Florida
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Saint Catherine Hospital Garden City Kansas
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Adams Cancer Center Gettysburg Pennsylvania
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Tacoma/Valley Radiation Oncology Centers-Gig Harbor Gig Harbor Washington
United States Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island Nebraska
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States Saint Rose Ambulatory and Surgery Center Great Bend Kansas
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Saint Francis Cancer Center Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Legacy Mount Hood Medical Center Gresham Oregon
United States WellSpan Medical Oncology and Hematology Hanover Pennsylvania
United States Hartford Hospital Hartford Connecticut
United States HaysMed Hays Kansas
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Island Urology Honolulu Hawaii
United States Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Kuakini Medical Center Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
United States Houston Methodist Hospital Houston Texas
United States Memorial Hermann Texas Medical Center Houston Texas
United States Methodist Willowbrook Hospital Houston Texas
United States Edwards Comprehensive Cancer Center Huntington West Virginia
United States Ascension Saint Vincent Indianapolis Hospital Indianapolis Indiana
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Sidney and Lois Eskenazi Hospital Indianapolis Indiana
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States University of Mississippi Medical Center Jackson Mississippi
United States Mayo Clinic in Florida Jacksonville Florida
United States MU Health Care Goldschmidt Cancer Center Jefferson City Missouri
United States Freeman Health System Joplin Missouri
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States North Kansas City Hospital Kansas City Missouri
United States The University of Kansas Cancer Center-South Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States University of Kansas Cancer Center - North Kansas City Missouri
United States CHI Health Good Samaritan Kearney Nebraska
United States Kettering Medical Center Kettering Ohio
United States UC San Diego Moores Cancer Center La Jolla California
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Lakeland Regional Health Hollis Cancer Center Lakeland Florida
United States Saint Anthony Hospital Lakewood Colorado
United States Memorial Medical Center - Las Cruces Las Cruces New Mexico
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri
United States Beebe Medical Center Lewes Delaware
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Littleton Adventist Hospital Littleton Colorado
United States Logan Regional Hospital Logan Utah
United States Longmont United Hospital Longmont Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Los Angeles General Medical Center Los Angeles California
United States Jewish Hospital Louisville Kentucky
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States UofL Health Medical Center Northeast Louisville Kentucky
United States University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Marietta Memorial Hospital Marietta Ohio
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Loyola University Medical Center Maywood Illinois
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States East Jefferson General Hospital Metairie Louisiana
United States Medical College of Wisconsin Milwaukee Wisconsin
United States University of Minnesota/Masonic Cancer Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Center Missoula Montana
United States Kaiser Permanente-Modesto Modesto California
United States UPMC Hillman Cancer Center in Coraopolis Moon Pennsylvania
United States West Virginia University Healthcare Morgantown West Virginia
United States Virtua Memorial Mount Holly New Jersey
United States Cooper CyberKnife Center Mount Laurel New Jersey
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Intermountain Medical Center Murray Utah
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Mount Sinai Chelsea New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Christiana Gynecologic Oncology LLC Newark Delaware
United States Delaware Clinical and Laboratory Physicians PA Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Newark Radiation Oncology Newark Ohio
United States Rutgers New Jersey Medical School Newark New Jersey
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Kaiser Permanente Oakland-Broadway Oakland California
United States Kaiser Permanente-Oakland Oakland California
United States McKay-Dee Hospital Center Ogden Utah
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Health Cancer Center Olathe Kansas
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Radiation Oncology of Northern Illinois Ottawa Illinois
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States Midlands Community Hospital Papillion Nebraska
United States OSF Saint Francis Radiation Oncology at Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Ascension Via Christi - Pittsburg Pittsburg Kansas
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States UPMC-Magee Womens Hospital Pittsburgh Pennsylvania
United States UPMC-Shadyside Hospital Pittsburgh Pennsylvania
United States Legacy Good Samaritan Hospital and Medical Center Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Illinois CancerCare-Princeton Princeton Illinois
United States Women and Infants Hospital Providence Rhode Island
United States Utah Valley Regional Medical Center Provo Utah
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Tacoma/Valley Radiation Oncology Centers-Puyallup Puyallup Washington
United States Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California
United States Rapid City Regional Hospital Rapid City South Dakota
United States Kaiser Permanente-Redwood City Redwood City California
United States Corewell Health Reed City Hospital Reed City Michigan
United States Center of Hope at Renown Medical Center Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Kaiser Permanente-Richmond Richmond California
United States Reid Health Richmond Indiana
United States Highland Hospital Rochester New York
United States Mayo Clinic in Rochester Rochester Minnesota
United States University of Rochester Rochester New York
United States Rohnert Park Cancer Center Rohnert Park California
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Kaiser Permanente-Roseville Roseville California
United States The Permanente Medical Group-Roseville Radiation Oncology Roseville California
United States Kaiser Permanente - Sacramento Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States South Sacramento Cancer Center Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Saint George Regional Medical Center Saint George Utah
United States Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Salina Regional Health Center Salina Kansas
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists-Salt Lake City Salt Lake City Utah
United States Kaiser Permanente-San Francisco San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser Permanente-San Rafael San Rafael California
United States Kaiser San Rafael-Gallinas San Rafael California
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Memorial Health University Medical Center Savannah Georgia
United States FHCC South Lake Union Seattle Washington
United States Kaiser Permanente Washington Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States Saint Michael Cancer Center Silverdale Washington
United States Robert Wood Johnson University Hospital Somerset Somerville New Jersey
United States South Jordan Health Center South Jordan Utah
United States Kaiser Permanente Cancer Treatment Center South San Francisco California
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Spartanburg Medical Center Spartanburg South Carolina
United States Central Illinois Hematology Oncology Center Springfield Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Medical Center Springfield Ohio
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Kaiser Permanente-Stockton Stockton California
United States Houston Methodist Sugar Land Hospital Sugar Land Texas
United States Southwest Illinois Health Services LLP Swansea Illinois
United States ProMedica Flower Hospital Sylvania Ohio
United States State University of New York Upstate Medical University Syracuse New York
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Tacoma/Valley Radiation Oncology Centers-Saint Joe's Tacoma Washington
United States Moffitt Cancer Center Tampa Florida
United States Houston Methodist The Woodlands Hospital The Woodlands Texas
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States Upper Valley Medical Center Troy Ohio
United States Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California
United States Legacy Meridian Park Hospital Tualatin Oregon
United States Banner University Medical Center - Tucson Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Carle Cancer Center Urbana Illinois
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States Kaiser Permanente-Vallejo Vallejo California
United States Legacy Salmon Creek Hospital Vancouver Washington
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey
United States Virtua Voorhees Voorhees New Jersey
United States University Hospitals Sharon Health Center Wadsworth Ohio
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Henry Ford West Bloomfield Hospital West Bloomfield Michigan
United States University of Cincinnati Cancer Center-West Chester West Chester Ohio
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa
United States Reading Hospital West Reading Pennsylvania
United States Saint Ann's Hospital Westerville Ohio
United States UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio
United States UHHS-Westlake Medical Center Westlake Ohio
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia
United States Asplundh Cancer Pavilion Willow Grove Pennsylvania
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Lankenau Medical Center Wynnewood Pennsylvania
United States University of Michigan Health - West Wyoming Michigan
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States WellSpan Health-York Cancer Center York Pennsylvania
United States WellSpan Health-York Hospital York Pennsylvania
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
National Cancer Institute (NCI) NRG Oncology

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants With Hematologic Toxicity During Treatment Period Number of participants with hematologic toxicity during treatment period, where hematologic toxicity is defined as occurrence of any grade 3 or higher adverse events for neutropenia, leukopenia, lymphopenia, anemia, or thrombocytopenia. Adverse events are graded and categorized using CTCAE v4.0. Up to 30 days after completion of study treatment
Other Number of Participants With Adverse Events (Grade 3 or Higher) That Occurred During Follow-Up Period Number of participants with a maximum grade of 3 or higher that occurred during follow-up period. Adverse events are graded and categorized using CTCAE v4.0. Up to 5 years
Other Peripheral Blood Methemoglobin Peripheral blood methemoglobin collected at baseline and 1, 3, 5 and 24 hours after Triapine infusion on Day 1 in Arm II. Baseline to 24 hours after triapine infusion
Other Metabolic Complete Response (mCR) The assessment of metabolic complete response is based on the ratio of post 3-month therapy PET/CT maximum standardized update value (SUV) to pre-therapy PET/CT maximum SUV. The metabolic complete response is classified as complete response for a ratio of 0.33 or less, or partial response for a ratio between 0.34 and 0.75, or stable response for a ratio greater that 0.75 but less than 1.25, or progressive response for a ratio greater than 1.25. Up to 3 months after completion of treatment
Other Intensity Modulated Radiation Therapy (IG-IMRT) Number of Participants with KBP IG-IMRT Up to 60 days.
Primary Overall Survival (OS) Rate at 3 Years Estimate for probability of overall survival at 3 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first. At 3 years from randomization.
Secondary Progression-free Survival (PFS) Rate at 3 Years Estimate for probability of progression free at 3 years by Kaplan-Meier method, where progression-free survival is defined as the time from randomization to the date of first documented disease recurrence/progression, death from any cause or date of last contact, whichever occurs first. Recurrence is defined as clinical, radiological or histological evidence of recurrent disease post study treatment. Disease progression will be determined from the physical examinations, which were conducted during treatment (day 9, 16, 23, 30 and 37) and follow-up (1 and 3 months after completing protocol therapy, every 3 months for years 1 and 2, and every 6 months for years 3, 4 and 5), and the PET/CT scan conducted 3 months after the end of treatment. Please note that progression defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) is not required by the protocol. At 3 years from study randomization.
Secondary Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0. During treatment period and up to 30 days after stopping the study treatment with a median treatment time as 53 days ranging from 1 to 189 days.
See also
  Status Clinical Trial Phase
Completed NCT02562729 - Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer Phase 2
Completed NCT00416455 - Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer Phase 1/Phase 2
Completed NCT00054444 - Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer Phase 1
Recruiting NCT05210348 - Clinical Evaluation of Detection of High Risk HPV in Urine
Active, not recruiting NCT02140021 - Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer N/A
Completed NCT00068549 - Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer Phase 1
Completed NCT01711515 - Chemoradiation Therapy and Ipilimumab in Treating Patients With Stages IB2-IIB or IIIB-IVA Cervical Cancer Phase 1
Terminated NCT00924066 - Ixabepilone to Treat Cervical Cancer Phase 2
Completed NCT00559377 - FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer Phase 2
Completed NCT00309959 - ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer Phase 2
Active, not recruiting NCT05613283 - Primary Cervical Cancer Screening by Self-sampling HPV Test
Recruiting NCT03742869 - HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma
Withdrawn NCT03834571 - Testing the Addition of Paclitaxel and Carboplatin Given After Standard Chemotherapy and Radiation for Cervical Cancer in HIV-positive Women Phase 2
Completed NCT01266460 - Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer Phase 2
Completed NCT00064077 - Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix Phase 3
Active, not recruiting NCT02257528 - Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer Phase 2
Completed NCT02164461 - Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer Phase 1
Completed NCT01281852 - Paclitaxel, Cisplatin, and Veliparib in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer Phase 1
Active, not recruiting NCT04622670 - Yoga Therapy During Chemotherapy and Radiation Treatment for the Improvement of Physical and Emotional Well-Being in Patients With Stage IB2-IIIB Cervical Cancer N/A
Completed NCT02921269 - Atezolizumab and Bevacizumab in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer Phase 2