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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00354835
Other study ID # ARST0531
Secondary ID NCI-2009-0042707
Status Completed
Phase Phase 3
First received
Last updated
Start date December 26, 2006
Est. completion date December 31, 2022

Study information

Verified date January 2023
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine sulfate, dactinomycin, cyclophosphamide, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma.


Description:

PRIMARY OBJECTIVES: I. To compare the early response rates, failure-free survival (FFS), and survival of patients with intermediate-risk rhabdomyosarcoma (RMS) treated with surgery, radiotherapy, and vincristine (vincristine sulfate), dactinomycin and cyclophosphamide (VAC) or VAC alternating with vincristine, irinotecan (irinotecan hydrochloride) (VI). SECONDARY OBJECTIVES: I. To compare FFS, local control, and survival of patients with intermediate-risk RMS treated with VAC and early (week 4) radiotherapy vs delayed (week 10) radiotherapy, using data from Intergroup Rhabdomyosarcoma Study (IRS)-IV for historic comparison. II. To compare the acute and late effects of VAC to VAC alternating with VI, including the toxicity associated with concurrent VI and radiotherapy. III. To compare the acute and late effects of VAC as delivered on this study to D9803 VAC. IV. To correlate change in fludeoxyglucose F-18 positron emission tomography (FDG-PET) maximum standard uptake value (SUVmax) from week 1 to week 4 and 15 with FFS. V. For VI treated patients, to correlate patient UDP glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) genotype with VI toxicity. VI. To correlate cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6), cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9), and glutathione S-transferase alpha 1 (GSTA1) genotypes with VAC toxicity. VII. To prospectively evaluate and validate gene expression values with the intent to define the best diagnostic predictors and more powerful prognostic classifiers. VIII. To assess the frequency of bladder dysfunction in patients with bladder, prostate, and pelvic sites of RMS 3-6 years after study enrollment. OUTLINE: Patients are randomized to 1 of 2 treatment arms within 42 days of initial surgery or biopsy. ARM I (VAC): Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. ARM II (VAC/VI): Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1,13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients* in both arms also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4 (except patients with alveolar RMS rendered group I by amputation OR patients needing week 1 emergency radiotherapy for symptomatic spinal cord compression). NOTE: *Individualized local control plan that deviates from protocol-mandated radiotherapy allowed for patients =< 24 months of age. After completion of study treatment, patients are followed up every 2-4 months for 4 years and then annually for 5-10 years.


Recruitment information / eligibility

Status Completed
Enrollment 481
Est. completion date December 31, 2022
Est. primary completion date December 31, 2014
Accepts healthy volunteers No
Gender All
Age group N/A to 49 Years
Eligibility Inclusion Criteria: - Patients with newly diagnosed embryonal RMS, botryoid or spindle cell variants of embryonal RMS, ectomesenchymoma, or alveolar RMS are eligible for this study - Enrollment on COG-D9902 to confirm local histologic diagnosis with central pathology review is required for all patients - Patients may be enrolled on ARST0531 and start protocol treatment prior to receipt of central pathology review results - Patient must have Intermediate-risk RMS defined as: - Embryonal, botryoid, or spindle cell RMS, or ectomesenchymoma: stage 2 or 3 and group III OR - Alveolar RMS: stage 1-3 and group I-III - Staging ipsilateral retroperitoneal lymph node dissection (SIRLND) is required for all patients >= 10 years of age with paratesticular tumors and for patients < 10 years with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement, defined as two or more lymph nodes > 2 cm in dimension, is identified by imaging studies) - Regional lymph node sampling or sentinel lymph node procedure is required for histologic evaluation in patients with extremity tumors - Clinically or radiographically enlarged nodes should be sampled for histologic evaluation - Detection of metastasis by optional FDG PET (not required for study enrollment); FDG PET may detect abnormalities suggestive of metastasis not identified by bone scan, computed tomography (CT), or bone marrow aspiration/biopsy; the prognostic significance of FDG PET-detected abnormalities is not clear; FDG PET-detected abnormalities MUST be confirmed to be metastases by an additional imaging modality (such as magnetic resonance imaging [MRI] or CT) OR pathologic confirmation; unless FDG PET abnormalities are confirmed by another imaging modality or biopsy, FDG PET abnormalities will NOT be considered evidence of metastasis - Patients must have a performance status of 0, 1, or 2; the Lansky performance score should be used for patients < 16 years and the Karnofsky performance score for patients >= 16 years - Patients who have received prior chemotherapy (excluding steroids) or radiation therapy, except for patients transferring from ARST0331 (low-risk study), are not eligible - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows: - 1 month to < 6 months: 0.4 mg/dL - 6 months to < 1 year: 0.5 mg/dL - 1 to < 2 years: 0.6 mg/dL - 2 to < 6 years: 0.8 mgt/dL - 6 to < 10 years: 1 mg/dL - 10 to < 13 years: 1.2 mg/dL - 13 to < 16 years: 1.5 mg/dL (males) or 1.4 mg/dL (females) - >= 16 years: 1.7 mg/dL (males) or 1.4 mg/dL (females) - Patients with urinary tract obstruction by tumor must meet the renal function criteria AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract - Total bilirubin =< 1.5 x upper limit of normal for age - Peripheral absolute neutrophil count (ANC) >= 750/uL - Platelet count >= 75,000/uL (transfusion independent) - No evidence of uncontrolled infection - Patients must be able to undergo radiation therapy, if necessary, as specified in the protocol - Female patients of childbearing potential must have a negative pregnancy test - Female patients who are breast feeding must agree to stop breast feeding - Sexually active patients of childbearing potential must be willing to use effective contraception during therapy and for at least 1 month after treatment is completed - All patients and/or their parents or legal guardians must sign a written informed consent - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Study Design


Related Conditions & MeSH terms

  • Adult Rhabdomyosarcoma
  • Childhood Alveolar Rhabdomyosarcoma
  • Childhood Botryoid-Type Embryonal Rhabdomyosarcoma
  • Childhood Embryonal Rhabdomyosarcoma
  • Rhabdomyosarcoma
  • Sarcoma
  • Stage I Adult Soft Tissue Sarcoma AJCC v7
  • Stage II Adult Soft Tissue Sarcoma AJCC v7
  • Stage III Adult Soft Tissue Sarcoma AJCC v7

Intervention

Drug:
Cyclophosphamide
Given IV
Biological:
Dactinomycin
Given IV
Drug:
Irinotecan Hydrochloride
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Radiation:
Radiation Therapy
Undergo radiotherapy
Drug:
Vincristine Sulfate
Given IV

Locations

Country Name City State
Australia Royal Brisbane and Women's Hospital Herston Queensland
Australia Royal Children's Hospital-Brisbane Herston Queensland
Australia Women's and Children's Hospital-Adelaide North Adelaide South Australia
Australia Royal Children's Hospital Parkville Victoria
Australia Princess Margaret Hospital for Children Perth Western Australia
Australia Sydney Children's Hospital Randwick New South Wales
Australia Queensland Children's Hospital South Brisbane Queensland
Australia The Children's Hospital at Westmead Westmead New South Wales
Australia Westmead Hospital Westmead New South Wales
Canada Alberta Children's Hospital Calgary Alberta
Canada University of Alberta Hospital Edmonton Alberta
Canada IWK Health Centre Halifax Nova Scotia
Canada McMaster Children's Hospital at Hamilton Health Sciences Hamilton Ontario
Canada Kingston Health Sciences Centre Kingston Ontario
Canada Children's Hospital London Ontario
Canada Victoria Hospital London Ontario
Canada Centre Hospitalier Universitaire Sainte-Justine Montreal Quebec
Canada The Montreal Children's Hospital of the MUHC Montreal Quebec
Canada Children's Hospital of Eastern Ontario Ottawa Ontario
Canada Centre Hospitalier Universitaire de Quebec Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Janeway Child Health Centre Saint John's Newfoundland and Labrador
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Hospital for Sick Children Toronto Ontario
Canada British Columbia Children's Hospital Vancouver British Columbia
Canada CancerCare Manitoba Winnipeg Manitoba
New Zealand Starship Children's Hospital Grafton Auckland
Puerto Rico San Jorge Children's Hospital San Juan
Switzerland Swiss Pediatric Oncology Group - Bern Bern
Switzerland Swiss Pediatric Oncology Group - Geneva Geneva
United States Children's Hospital Medical Center of Akron Akron Ohio
United States Albany Medical Center Albany New York
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Texas Tech University Health Sciences Center-Amarillo Amarillo Texas
United States C S Mott Children's Hospital Ann Arbor Michigan
United States Mission Hospital Asheville North Carolina
United States Children's Healthcare of Atlanta - Egleston Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Children's Hospital Colorado Aurora Colorado
United States Dell Children's Medical Center of Central Texas Austin Texas
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Walter Reed National Military Medical Center Bethesda Maryland
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Children's Hospital of Alabama Birmingham Alabama
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Brooklyn Hospital Center Brooklyn New York
United States Roswell Park Cancer Institute Buffalo New York
United States University of Vermont and State Agricultural College Burlington Vermont
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States University of Virginia Cancer Center Charlottesville Virginia
United States T C Thompson Children's Hospital Chattanooga Tennessee
United States Lurie Children's Hospital-Chicago Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Rainbow Babies and Childrens Hospital Cleveland Ohio
United States Prisma Health Richland Hospital Columbia South Carolina
United States University of Missouri - Ellis Fischel Columbia Missouri
United States Nationwide Children's Hospital Columbus Ohio
United States Driscoll Children's Hospital Corpus Christi Texas
United States Medical City Dallas Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States Dayton Children's Hospital Dayton Ohio
United States Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado
United States Blank Children's Hospital Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Kaiser Permanente Downey Medical Center Downey California
United States City of Hope Comprehensive Cancer Center Duarte California
United States Duke University Medical Center Durham North Carolina
United States Michigan State University Clinical Center East Lansing Michigan
United States Inova Fairfax Hospital Falls Church Virginia
United States Sanford Broadway Medical Center Fargo North Dakota
United States University of Connecticut Farmington Connecticut
United States Hurley Medical Center Flint Michigan
United States Broward Health Medical Center Fort Lauderdale Florida
United States Golisano Children's Hospital of Southwest Florida Fort Myers Florida
United States Lee Memorial Health System Fort Myers Florida
United States Cook Children's Medical Center Fort Worth Texas
United States University of Florida Health Science Center - Gainesville Gainesville Florida
United States Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States BI-LO Charities Children's Cancer Center Greenville South Carolina
United States Greenville Cancer Treatment Center Greenville South Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Connecticut Children's Medical Center Hartford Connecticut
United States Penn State Children's Hospital Hershey Pennsylvania
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas
United States M D Anderson Cancer Center Houston Texas
United States Ascension Saint Vincent Indianapolis Hospital Indianapolis Indiana
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Riley Hospital for Children Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States University of Mississippi Medical Center Jackson Mississippi
United States Nemours Children's Clinic-Jacksonville Jacksonville Florida
United States Bronson Methodist Hospital Kalamazoo Michigan
United States Kalamazoo Center for Medical Studies Kalamazoo Michigan
United States Children's Mercy Hospitals and Clinics Kansas City Missouri
United States East Tennessee Childrens Hospital Knoxville Tennessee
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Nevada Cancer Research Foundation NCORP Las Vegas Nevada
United States Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Arkansas Children's Hospital Little Rock Arkansas
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Loma Linda University Medical Center Loma Linda California
United States Miller Children's and Women's Hospital Long Beach Long Beach California
United States Cedars Sinai Medical Center Los Angeles California
United States Children's Hospital Los Angeles Los Angeles California
United States Mattel Children's Hospital UCLA Los Angeles California
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California
United States Norton Children's Hospital Louisville Kentucky
United States Covenant Children's Hospital Lubbock Texas
United States Valley Children's Hospital Madera California
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Loyola University Medical Center Maywood Illinois
United States Saint Jude Children's Research Hospital Memphis Tennessee
United States Miami Cancer Institute Miami Florida
United States Nicklaus Children's Hospital Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Children's Hospital of Wisconsin Milwaukee Wisconsin
United States NYU Winthrop Hospital Mineola New York
United States Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota
United States University of Minnesota/Masonic Cancer Center Minneapolis Minnesota
United States Morristown Medical Center Morristown New Jersey
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey
United States Saint Peter's University Hospital New Brunswick New Jersey
United States Yale University New Haven Connecticut
United States The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York
United States Children's Hospital New Orleans New Orleans Louisiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Mount Sinai Hospital New York New York
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Newark Beth Israel Medical Center Newark New Jersey
United States Children's Hospital of The King's Daughters Norfolk Virginia
United States Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois
United States Kaiser Permanente-Oakland Oakland California
United States UCSF Benioff Children's Hospital Oakland Oakland California
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Children's Hospital and Medical Center of Omaha Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Children's Hospital of Orange County Orange California
United States AdventHealth Orlando Orlando Florida
United States Arnold Palmer Hospital for Children Orlando Florida
United States Nemours Children's Clinic - Orlando Orlando Florida
United States Nemours Children's Hospital Orlando Florida
United States Orlando Health Cancer Institute Orlando Florida
United States Lucile Packard Children's Hospital Stanford University Palo Alto California
United States Advocate Lutheran General Hospital Park Ridge Illinois
United States Saint Joseph's Regional Medical Center Paterson New Jersey
United States Nemours Children's Clinic - Pensacola Pensacola Florida
United States Sacred Heart Hospital Pensacola Florida
United States Saint Jude Midwest Affiliate Peoria Illinois
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Phoenix Childrens Hospital Phoenix Arizona
United States Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania
United States Legacy Emanuel Children's Hospital Portland Oregon
United States Legacy Emanuel Hospital and Health Center Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Mayo Clinic in Rochester Rochester Minnesota
United States University of Rochester Rochester New York
United States Beaumont Children's Hospital-Royal Oak Royal Oak Michigan
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Sutter Medical Center Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Johns Hopkins All Children's Hospital Saint Petersburg Florida
United States Primary Children's Hospital Salt Lake City Utah
United States Methodist Children's Hospital of South Texas San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Rady Children's Hospital - San Diego San Diego California
United States UCSF Medical Center-Mission Bay San Francisco California
United States UCSF Medical Center-Mount Zion San Francisco California
United States UCSF Medical Center-Parnassus San Francisco California
United States Santa Barbara Cottage Hospital Santa Barbara California
United States Memorial Health University Medical Center Savannah Georgia
United States Maine Children's Cancer Program Scarborough Maine
United States Seattle Children's Hospital Seattle Washington
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington
United States Baystate Medical Center Springfield Massachusetts
United States Southern Illinois University School of Medicine Springfield Illinois
United States Stony Brook University Medical Center Stony Brook New York
United States Overlook Hospital Summit New Jersey
United States State University of New York Upstate Medical University Syracuse New York
United States Madigan Army Medical Center Tacoma Washington
United States Mary Bridge Children's Hospital and Health Center Tacoma Washington
United States Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida
United States Scott and White Memorial Hospital Temple Texas
United States Mercy Children's Hospital Toledo Ohio
United States ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio
United States University of Toledo Toledo Ohio
United States Harbor-University of California at Los Angeles Medical Center Torrance California
United States Banner University Medical Center - Tucson Tucson Arizona
United States Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma
United States New York Medical College Valhalla New York
United States Children's National Medical Center Washington District of Columbia
United States MedStar Georgetown University Hospital Washington District of Columbia
United States Saint Mary's Hospital West Palm Beach Florida
United States Alfred I duPont Hospital for Children Wilmington Delaware
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States UMass Memorial Medical Center - University Campus Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand,  Puerto Rico,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Event Free Survival (EFS) Probability of no relapse, secondary malignancy, or death after 4 year in the study 4 years
Primary Response Rate (RR) Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at > 4 weeks; Partial Response (PR): At least 64% decrease in volume compared to the baseline; Overall Response (OR) = CR + PR. Reporting Period 1 (Weeks 1 - 15)
Primary Overall Survival (OS) Probability of being alive after 4 years in the study. 4 years
Secondary Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison Compare 4-year EFS using eligible participants only to the historical rate of 0.65 with IRSI-V. The 4-year EFS is probability of no relapse, secondary malignancy, or death after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.65. 4 years
Secondary Local Failure Compare 2-year local failure rate to the historical rate of 0.13 with IRSI-V. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.13. 2 years
Secondary Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison Compare 4-year OS using eligible participants only to the historical rate of 0.70 with IRSI-V. The 4-year OS is probability of being alive after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.70. 4 years
Secondary Incidence of Toxicity Grade 3 or 4 nausea, diarrhea, dehydration, radiation dermatitis, mucositis due to radiation. Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3. Up to 15 weeks
Secondary Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons. Up to 43 weeks
Secondary Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4 4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study). 4 years
Secondary Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15 4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study) 4 years
Secondary Incidence of Toxicity Related to VI Treatment in Patients With UGT1A1 Genotype Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3. Weeks 4-9 (the first exposure to VI)
Secondary Toxicity With CYP2B6 Genotypes Incidence of toxicity related to VAC treatment in patients with CYP2B6 genotypes. During the study
Secondary Toxicity With GSTA1 and CYP2C9 Genotypes Incidence of toxicity related to VAC treatment in patients with GSTA1 and CYP2C9 genotypes. During the study
Secondary Event Free Survival (EFS) by PAX Status 4 years
Secondary Incidence of Bladder Dysfunction Number of patients with a summary score greater than 8.5 3-6 years after enrollment
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