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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02254278
Other study ID # NRG-HN002
Secondary ID NCI-2014-01279NR
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 2014
Est. completion date May 31, 2025

Study information

Verified date October 2021
Source NRG Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II trial studies the side effects and how well modestly reduced-dose intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating patients with oropharyngeal cancer that has spread to other places in the body (advanced). Radiation therapy uses high energy x rays to kill tumor cells. 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. It is not yet known whether IMRT is more effective with or without cisplatin in treating patients with oropharyngeal cancer.


Description:

PRIMARY OBJECTIVES: -To select the arm(s) achieving a 2-year progression-free survival rate of >= 85% without unacceptable swallowing toxicity at 1 year. SECONDARY OBJECTIVES: - To determine patterns of failure (locoregional relapse versus distant) and survival -(overall and progression-free) at 6 months and 2 years. - To determine acute toxicity profiles at the end of radiation therapy and at 1 and 6 months. - To determine late toxicity profiles at 1 and 2 years. - To determine patient-reported swallowing outcomes at 6 months and 1 and 2 years. - To determine the predictive value of 12-14 week, post-treatment fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) for locoregional control and progression free survival (PFS) at 2 years. - To determine the predictive value of blood and tissue biomarkers for disease outcomes at 2 years. - To determine swallowing recovery per videofluoroscopy imaging at 2 years. After completion of study treatment, patients are followed at 1 and 3 months then every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 316
Est. completion date May 31, 2025
Est. primary completion date June 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria Step 1: Registration: 1. Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage). 2. Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving = 4 nodes are permitted and considered as non-therapeutic nodal excisions. 3. Immunohistochemical staining for p16 must be performed on tissue, and this tissue must be submitted for central review. Fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue if formalin-fixed paraffin-embedded cell block material is available for p16 immunohistochemistry. FNA specimens prepared with adequate p16 testing in this manner are acceptable to submit for central review. If the p16 preparation is not adequate, additional specimens will be required to establish p16 status. Centers are encouraged to contact the pathology chairs for clarification. 4. Clinical stage T1-T2, N1-N2b or T3, N0-N2b (AJCC, 7th ed.) including no distant metastases based on the following diagnostic workup: - General history and physical examination within 56 days prior to registration; - Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 70 days prior to registration; - One of the following combinations of imaging is required within 56 days prior to registration: 1. A computed tomography (CT) scan of the neck (with contrast) and a chest CT scan (with or without contrast); 2. or an MRI of the neck (with contrast) and a chest CT scan (with or without contrast); 3. or a CT scan of neck (with contrast) and a PET/CT of neck and chest (with or without contrast); 4. or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast). Note: A CT scan of neck and/or a PET/CT performed for the purposes of radiation planning may serve as both staging and planning tools. 5. Patients must provide their personal smoking history prior to registration. The lifetime cumulative history cannot exceed 10 pack-years. The following formula is used to calculate the pack-years during the periods of smoking in the patient's life; the cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history. Number of pack-years = [Frequency of smoking (number of cigarettes per day) × duration of cigarette smoking (years)] / 20 Note: Twenty cigarettes is considered equivalent to one pack. The effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined. While there are reportedly increased risks of head and neck cancer associated with sustained heavy cigar and pipe use (Wyss 2013), such sustained use of non-cigarette products is unusual and does not appear to convey added risk with synchronous cigarette smoking. Cigar and pipe tobacco consumption is therefore not included in calculating the lifetime pack-years. Marijuana consumption is likewise not considered in this calculation. There is no clear scientific evidence regarding the role of chewing tobacco-containing products in this disease, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, investigators are discouraged from enrolling patients with a history of very sustained use (such as several years or more) of non-cigarette tobacco products alone. 6. Zubrod Performance Status of 0-1 within 56 days prior to registration; 7. Age = 18; 8. The trial is open to both genders; 9. Adequate hematologic function within 14 days prior to registration, defined as follows: - Absolute neutrophil count (ANC) = 1,500 cells/mm3; - Platelets = 100,000 cells/mm3; - Hemoglobin (Hgb) = 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb = 8.0 g/dl is acceptable. 10. Adequate renal function within 14 days prior to registration, defined as follows: • Serum creatinine (Cr) < 1.5 mg/dl or creatinine clearance (CC) = 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula: - CC male = [(140 - age) x (wt in kg)] / [(Serum Cr mg/dl) x (72)] - CC female = 0.85 x (CC male) 11. Adequate hepatic function within 14 days prior to registration defined as follows: - Bilirubin < 2 mg/dl; - Aspartate transaminase (AST) or alanine transaminase (ALT) < 3 x the upper limit of normal. 12. Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential; 13. Patients who are HIV positive but have no prior Acquired Immune Deficiency Syndrome (AIDS) -defining illness and have CD4 cells of at least 350/mm3 are eligible. HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions. Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B). 14. The patient must provide study-specific informed consent prior to study entry, including consent for mandatory submission of tissue for required, central p16 review. 15. Patients who speak English (or read one of the languages for which a translation is available (see Section 10.2) must consent to complete the mandatory dysphagia-related patient reported instrument (MDADI). If the patient cannot understand spoken English and reads only languages not available in the MDADI translations, the patient can still participate in the trial, as this has been factored into the trial statistics. For all other patients, the MDADI is mandatory as it is included in the primary endpoint to be studied. Step 2: Randomization: 16. p16 positive by immunohistochemistry (defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells), confirmed by central pathology review; (see Section 10.1 for details). Exclusion Criteria Step 1: Registration: 1. Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas; 2. Carcinoma of the neck of unknown primary site origin (even if p16 positive); 3. Radiographically matted nodes, defined as 3 abutting nodes with loss of the intervening fat plane; 4. Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle; 5. Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles; 6. Gross total excision of both primary and nodal disease with curative intent; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed. 7. Patients with simultaneous primary cancers or separate bilateral primary tumor sites are excluded with the exception of patients with bilateral tonsil cancers; 8. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible); 9. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; 10. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; 11. Severe, active co-morbidity defined as follows: - Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; - Transmural myocardial infarction within the last 6 months; - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; - Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration; - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those requested in Section 3.2.10. - Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition with immune compromise greater than that noted in Inclusion Criterion 13; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients. 12. Pregnancy; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. 13. Prior allergic reaction to cisplatin.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cisplatin
40 mg/m2 IV (intravenously) weekly for 6 weeks
Radiation:
IMRT 6 weeks
Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
IMRT 5 weeks
Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy

Locations

Country Name City State
Canada Tom Baker Cancer Centre Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada Juravinski Cancer Centre at Hamilton Health Sciences Hamilton Ontario
Canada Kingston Health Sciences Centre Kingston Ontario
Canada CHUM - Hopital Notre-Dame Montreal Quebec
Canada Jewish General Hospital Montreal Quebec
Canada McGill University Department of Oncology Montreal Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto Ontario
Canada University Health Network-Princess Margaret Hospital Toronto Ontario
Canada BCCA-Vancouver Island Cancer Centre Victoria British Columbia
Canada Windsor Regional Cancer Centre Windsor Ontario
Ireland Saint Lukes Hospital Dublin Co Dublin
Saudi Arabia King Faisal Specialist Hospital and Research Centre Riyadh
United States Abington Memorial Hospital Abington Pennsylvania
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Mission Hospital Inc-Memorial Campus Asheville North Carolina
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 Grady Health System Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States University of Colorado Hospital Aurora Colorado
United States Greater Baltimore Medical Center Baltimore Maryland
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Billings Clinic Cancer Center Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Boston Medical Center Boston Massachusetts
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Henry Ford Cancer Institute-Downriver Brownstown Michigan
United States Mills-Peninsula Medical Center Burlingame California
United States Lahey Hospital and Medical Center Burlington Massachusetts
United States Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
United States Geauga Hospital Chardon Ohio
United States Medical University of South Carolina Charleston South Carolina
United States University of Virginia Cancer Center Charlottesville Virginia
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Northwestern University Chicago Illinois
United States University of Cincinnati/Barrett Cancer Center Cincinnati Ohio
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 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States Mercy Hospital Coon Rapids Minnesota
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Decatur Memorial Hospital Decatur Illinois
United States Henry Ford Hospital Detroit Michigan
United States Wentworth-Douglass Hospital Dover New Hampshire
United States City of Hope Comprehensive Cancer Center Duarte California
United States Mercy Cancer Center-Elyria Elyria Ohio
United States Swedish Medical Center Englewood Colorado
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Poudre Valley Hospital Fort Collins Colorado
United States Parkview Hospital Randallia Fort Wayne Indiana
United States Radiation Oncology Associates PC Fort Wayne Indiana
United States University of Texas Medical Branch Galveston Texas
United States Tacoma/Valley Radiation Oncology Centers-Gig Harbor Gig Harbor Washington
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States CHI Health Saint Francis Grand Island Nebraska
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Marin General Hospital Greenbrae California
United States UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania
United States Greenville Health System Cancer Institute-Eastside Greenville South Carolina
United States Greenville Health System Cancer Institute-Faris Greenville South Carolina
United States Greenville Health System Cancer Institute-Greer Greer South Carolina
United States Legacy Mount Hood Medical Center Gresham Oregon
United States Memorial Sloan Kettering Westchester Harrison New York
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida
United States Queen's Medical Center Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States M D Anderson Cancer Center Houston Texas
United States MD Anderson in Katy Houston Texas
United States Cleveland Clinic Cancer Center Independence Independence Ohio
United States UW Cancer Center Johnson Creek Johnson Creek Wisconsin
United States UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania
United States North Kansas City Hospital Kansas City Missouri
United States The University of Kansas Cancer Center-North 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 Vidant Oncology-Kinston Kinston North Carolina
United States Tennessee Cancer Specialists-Dowell Springs Knoxville Tennessee
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States UC San Diego Moores Cancer Center La Jolla California
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States UTMB Cancer Center at Victory Lakes League City Texas
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States The University of Kansas Cancer Center-Lee's Summit Lee's Summit Missouri
United States Saint Barnabas Medical Center Livingston New Jersey
United States Saint Mary Mercy Hospital Livonia Michigan
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Jewish Hospital Medical Center Northeast Louisville Kentucky
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Loyola University Medical Center Maywood Illinois
United States UPMC Cancer Center at UPMC McKeesport McKeesport Pennsylvania
United States Community Memorial Hospital Menomonee Falls Wisconsin
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States Miami Cancer Institute Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Community Medical Hospital Missoula Montana
United States Memorial Medical Center Modesto California
United States UPMC-Coraopolis/Heritage Valley Radiation Oncology Moon Pennsylvania
United States Virtua Memorial Mount Holly New Jersey
United States Intermountain Medical Center Murray Utah
United States Mercy Health Mercy Campus Muskegon Michigan
United States MD Anderson League City Nassau Bay Texas
United States Yale University New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Kaiser Permanente Oakland-Broadway Oakland California
United States McKay-Dee Hospital Center Ogden Utah
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Medical Center Olathe Kansas
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital 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 University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States Parker Adventist Hospital Parker Colorado
United States University Hospitals Parma Medical Center Parma Ohio
United States Memorial Hospital West Pembroke Pines Florida
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States UPMC-Passavant Hospital Pittsburgh Pennsylvania
United States UPMC-Saint Margaret Pittsburgh Pennsylvania
United States UPMC-Shadyside Hospital Pittsburgh Pennsylvania
United States Ascension All Saints Hospital Racine Wisconsin
United States Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California
United States Beebe Health Campus Rehoboth Beach Delaware
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Rohnert Park Cancer Center Rohnert Park California
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
United States The Permanente Medical Group-Roseville Radiation Oncology Roseville California
United States South Sacramento Cancer Center Sacramento California
United States Sutter Medical Center Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota
United States Saint Helena Hospital Saint Helena California
United States Norris Cotton Cancer Center-North Saint Johnsbury Vermont
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States Utah Cancer Specialists-Salt Lake City Salt Lake City Utah
United States Naval Medical Center -San Diego San Diego California
United States UCSF Medical Center-Mount Zion San Francisco California
United States Stanford Cancer Center South Bay San Jose California
United States North Coast Cancer Care Sandusky Ohio
United States UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Virginia Mason Medical Center Seattle Washington
United States Greenville Health System Cancer Institute-Seneca Seneca South Carolina
United States UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Memorial Hospital of South Bend South Bend Indiana
United States City of Hope South Pasadena South Pasadena California
United States Kaiser Permanente Cancer Treatment Center South San Francisco California
United States Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina
United States Spartanburg Medical Center Spartanburg South Carolina
United States CoxHealth South Hospital Springfield Missouri
United States Mercy Hospital Springfield Springfield Missouri
United States Cleveland Clinic Cancer Center Strongsville Strongsville Ohio
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States NHRMC Radiation Oncology - Supply Supply North Carolina
United States ProMedica Flower Hospital Sylvania Ohio
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Tacoma/Valley Radiation Oncology Centers-Jackson Hall Tacoma Washington
United States Tacoma/Valley Radiation Oncology Centers-Saint Joe's Tacoma Washington
United States Moffitt Cancer Center Tampa Florida
United States MD Anderson in The Woodlands The Woodlands Texas
United States Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California
United States Banner University Medical Center - Tucson Tucson Arizona
United States Memorial Sloan Kettering Nassau Uniondale New York
United States UPMC Uniontown Hospital Radiation Oncology Uniontown Pennsylvania
United States Legacy Salmon Creek Hospital Vancouver Washington
United States Virtua Voorhees Voorhees New Jersey
United States John Muir Medical Center-Walnut Creek Walnut Creek California
United States UPMC Washington Hospital Radiation Oncology Washington Pennsylvania
United States The Alyce and Elmore Kraemer Cancer Care Center West Bend Wisconsin
United States Henry Ford West Bloomfield Hospital West Bloomfield Michigan
United States University Pointe West Chester Ohio
United States Reading Hospital West Reading Pennsylvania
United States UHHS-Westlake Medical Center Westlake Ohio
United States Cleveland Clinic-Weston Weston Florida
United States Dickstein Cancer Treatment Center White Plains New York
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States NHRMC Radiation Oncology - 16th Street Wilmington North Carolina
United States Aspirus UW Cancer Center Wisconsin Rapids Wisconsin
United States Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio

Sponsors (2)

Lead Sponsor Collaborator
NRG Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Ireland,  Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival) Progression is defined as local, regional, or distant disease progression or death due to any cause. Percentage is estimated using the binomial distribution. From randomization to 2 years
Secondary Percentage of Participants With Local-regional Failure Local-regional failure is defined as local or regional progression, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown > 20 weeks after the end of radiation therapy, death due to study cancer without documented progression, or death due to unknown causes without documented progression. Distant metastasis and death due to other causes are considered competing risks. Local-regional failure time is defined as time from randomization to the date of first progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. From randomization to 2 years
Secondary Percentage of Participants With Distant Metastasis Distant metastasis is defined as distant progression. Local-regional failure and death due to any cause are considered competing risks. Distant metastasis time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the cumulative incidence method. From randomization to 2 years
Secondary Percentage of Participants Alive Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. from randomization to 2 years
Secondary Percentage of Participants With Grade 3+ Adverse Events Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. End of radiation therapy (RT) (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2), then 1 month, 6 months, 1 year, and two years after end of RT
Secondary Mean One-year Total MD Anderson Dysphagia Inventory (MDADI) Score (Patient-reported Swallowing Outcome) The MDADI is a 20-item tool with each item scored as Strongly agree; Agree; No opinion; Disagree; or Strongly disagree. There is 1 global item (G1), 6 emotional subscale items (E2-E7), 5 functional subscale items (F1-F5), and 8 physical subscale items (P1-P8). For all items except E7 and F2, Strongly agree corresponds to a score of 1, Agree 2, No opinion 3, Disagree 4, and Strongly disagree 5. For E7 and F2, the scores are reversed; these 2 items are rescored to match the others before calculating summary scores. The composite (total) score is the mean of the 19 items (other than G1) X 20. Composite scores range from 20 to 100 with higher scores indicating less dysphagia. One year post-RT. Radiation therapy (RT) ends at approximately 6 weeks for Arm 1 and 5 weeks for Arm 2
Secondary Negative Predictive Value (NPV) of Post-treatment FDG-PET/CT Scan [Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT)] for Progression-free Survival and Local-regional Control at Two Years NPV is the percentage of participants alive and failure-free at 2 years among those with a negative post-treatment scan, as evaluated by central review. Negative scan determined as follows: primary site, right neck, left neck evaluated using a 5-point ordinal scale: 1-Definite complete metabolic response (CMR), 2-Likely CMR, 3-Likely inflammatory, 4-Likely residual metabolic disease (RMD), and 5-Definite RMD. 'Negative'= 1 or 2, 'Indeterminate'=3, 'Positive' = 4 or 5. 'Negative' for all three evaluation sites = overall score of 'Negative.' Progression (failure) is defined as local, regional, or distant disease progression (PR) or any death. Local-regional progression (failure) is defined as local or regional PR, salvage surgery of the primary tumor with tumor present/unknown, salvage neck dissection with tumor present/unknown > 20 weeks post RT, death due to study cancer or unknown causes without documented PR. The protocol specified that both arms would be combined for analysis. 3 months (scan) and two years after the end of RT (approximately 6 weeks for Arm 1 and 5 weeks for Arm 2)
Secondary Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Detection Rate With a two-sided type error rate of 5% and based on chi-squared test for proportions, there is a greater than 99% power to detect HPV DNA detection rate of 65% and 95% between the 2 groups (n=140 in each arm). The rate of detection for each group will be summarized based on binomial distributions and a 95% confidence intervals (CI) will be provided. Baseline to up to 2 weeks after the completion of treatment
Secondary HPV DNA Rate Decline With a two-sided type error rate of 5% and based on paired t test for means, there is 99% power to detect HPV DNA rate decline of 0.375 (effect size) within each arm (n=140). The HPV DNA rate for each group will be summarized using means and standard deviations. Baseline to up to 2 weeks after the completion of treatment
Secondary HPV DNA Copy Number Correlation between HPV DNA copy number and the nodal metabolic volume will be calculated using Spearman's correlation coefficient and R2, and the corresponding 95% CI will be provided. Baseline to up to 2 weeks after the completion of treatment
Secondary Variance for HPV DNA Univariable and multivariable cause specific analysis will be performed using the Cox proportional hazards model for rate of relapse. Baseline to up to 2 weeks after the completion of treatment
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