Information obtained from ClinicalTrials.gov on May 23, 2013Link to the current ClinicalTrials.gov record.http://clinicaltrials.gov/show/NCT00002546CDR0000063303GOG-0150ECOG-G150NCT00002546Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the UterusA Phase III Randomized Study of Accelerated Hyperfractionated Whole Abdominal Radiotherapy (AHWAR) Versus Combination Ifosfamide-Mesna With Cisplatin in Optimally Debulked Stage I, II, III, or IV Carcinosarcoma (CS) of The UterusGynecologic Oncology GroupOtherNational Cancer Institute (NCI)NIHEastern Cooperative Oncology GroupOtherNational Cancer Institute (NCI)United States: Federal Government
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. It is not yet known whether radiation therapy is more effective than combination
chemotherapy in treating patients with cancer of the uterus.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it
works compared to combination chemotherapy in treating patients with cancer of the uterus.
OBJECTIVES:
- Compare the survival, progression-free interval, and failure patterns in patients with
optimally debulked stage I-IV carcinosarcoma of the uterus treated with whole abdominal
radiotherapy vs ifosfamide and cisplatin.
- Compare the incidence and type of acute and late adverse events observed with these
treatment regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms.
- Arm I: Patients receive whole abdominal radiotherapy 5 days a week for 4 weeks,
followed by radiotherapy boost to the pelvis 5 days a week for 2.2 weeks.
- Arm II: Patients receive cisplatin IV followed by ifosfamide IV over 1 hour on days
1-4. Treatment continues every 3 weeks for 3 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 6 years.
CompletedDecember 1993January 2009Phase 3InterventionalAllocation: Randomized, Primary Purpose: Treatment216SarcomaDrugcisplatinDrugifosfamideProcedureadjuvant therapyRadiationradiation therapy
DISEASE CHARACTERISTICS:
- Histologically confirmed primary homologous or heterologous carcinosarcoma of the
uterus (corpus and cervix)
- Surgical stage I-IV disease, including positive adnexa, tumor invading the serosa,
positive pelvic and/or para-aortic nodes, involvement of the mucosa of the bowel,
bladder, or rectum, intra-abdominal metastases, positive pelvic washings, or vaginal
involvement within planned radiation port
- Prior total abdominal hysterectomy with bilateral salpingo-oophorectomy and maximum
tumor resection of all gross intra-abdominal/pelvic disease, including grossly
involved pelvic and para-aortic nodes within 8 weeks before study
- No greater than 1 cm residual disease
- Cervical sarcomas also allowed
- No metastasis beyond the abdominal cavity at diagnosis, including the following:
- Parenchymal liver metastasis
- Lung metastasis
- Positive inguinal lymph nodes
- Positive scalene nodes
- Radiographic or pathologic evidence of bone or brain metastasis
PATIENT CHARACTERISTICS:
Age:
- 21 and over
Performance status:
- GOG 0-2
Hematopoietic:
- WBC at least 3,000/mm3
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 3 times normal
- Albumin at least 3 g/dL
- No acute hepatitis
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 50 mL/min
Other:
- No septicemia
- No severe infection
- No severe gastrointestinal bleeding
- No prior invasive or concurrent malignancy within the past 5 years except nonmelanoma
skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Prior hormonal therapy allowed
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No prior therapy that would preclude study therapy
Female21 YearsN/ANoAaron H. Wolfson, MDStudy ChairUniversity of Miami Sylvester Comprehensive Cancer CenterHiginia R. Cardenes, MD, PhDStudy ChairIndiana University Melvin and Bren Simon Cancer CenterUniversity of Alabama at Birmingham Comprehensive Cancer CenterBirminghamAlabama35294-3300United StatesCCOP - Western Regional, ArizonaPhoenixArizona85006-2726United StatesWomen's Cancer Center - Los GatosLos GatosCalifornia95032United StatesChao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrangeCalifornia92868United StatesUniversity of Colorado Cancer Center at University of Colorado Health Sciences CenterDenverColorado80010United StatesCCOP - Christiana Care Health ServicesNewarkDelaware19713United StatesWalter Reed Army Medical CenterWashingtonDistrict of Columbia20307-5001United StatesUniversity of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136United StatesUniversity of Chicago Cancer Research CenterChicagoIllinois60637-1470United StatesMBCCOP - University of Illinois at ChicagoChicagoIllinois60612United StatesRush University Medical CenterChicagoIllinois60612-3824United StatesCCOP - Central IllinoisDecaturIllinois62794-9640United StatesCCOP - EvanstonEvanstonIllinois60201United StatesHinsdaleIllinois60521United StatesCCOP - Carle Cancer CenterUrbanaIllinois61801United StatesIndiana University Cancer CenterIndianapolisIndiana46202-5289United StatesCCOP - Northern Indiana CR ConsortiumSouth BendIndiana46601United StatesSaint Joseph Regional Medical CenterSouth BendIndiana46617United StatesHolden Comprehensive Cancer Center at University of IowaIowa CityIowa52242-1002United StatesCancer Center at Tufts - New England Medical CenterBostonMassachusetts02111United StatesUMASS Memorial Cancer Center - University CampusWorcesterMassachusetts01605-2982United StatesCCOP - Michigan Cancer Research ConsortiumAnn ArborMichigan48106United StatesBarbara Ann Karmanos Cancer InstituteDetroitMichigan48201United StatesCCOP - Grand RapidsGrand RapidsMichigan49503United StatesCCOP - KalamazooKalamazooMichigan49007-3731United StatesUniversity of Minnesota Cancer CenterMinneapolisMinnesota55455United StatesCCOP - Metro-MinnesotaSaint Louis ParkMinnesota55416United StatesUniversity of Mississippi Medical CenterJacksonMississippi39216-4505United StatesKeesler Medical Center - Keesler Air Force BaseKeesler AFBMississippi39534-2576United StatesEllis Fischel Cancer Center at University of Missouri - ColumbiaColumbiaMissouri65203United StatesCCOP - Kansas CityKansas CityMissouri64131United StatesSiteman Cancer Center at Barnes-Jewish HospitalSaint LouisMissouri63110United StatesCCOP - Cancer Research for the OzarksSpringfieldMissouri65807United StatesCCOP - Missouri Valley Cancer ConsortiumOmahaNebraska68106United StatesCCOP - Southern Nevada Cancer Research FoundationLas VegasNevada89106United StatesNorris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-0002United StatesCancer Institute of New Jersey at the Cooper University HospitalCamdenNew Jersey08103-1489United StatesMBCCOP - University of New Mexico HSCAlbuquerqueNew Mexico87131United StatesMemorial Sloan-Kettering Cancer CenterNew YorkNew York10021United StatesLong Island Cancer Center at Stony Brook University HospitalStony BrookNew York11790-7775United StatesLineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7570United StatesDuke Comprehensive Cancer CenterDurhamNorth Carolina27710United StatesGynecologic Oncology NetworkGreenvilleNorth Carolina27858United StatesComprehensive Cancer Center at Wake Forest UniversityWinston-SalemNorth Carolina27157-1065United StatesCharles M. Barrett Cancer Center at University HospitalCincinnatiOhio45267-0526United StatesMetroHealth's Cancer Care Center at MetroHealth Medical CenterClevelandOhio44106United StatesArthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbusOhio43210-1240United StatesUniversity of Oklahoma College of MedicineOklahoma CityOklahoma73104United StatesCCOP - Columbia River Oncology ProgramPortlandOregon97225United StatesAbington Memorial HospitalAbingtonPennsylvania19001-3788United StatesCCOP - Geisinger Clinic and Medical CenterDanvillePennsylvania17822-2001United StatesPenn State Cancer Institute at Milton S. Hershey Medical CenterHersheyPennsylvania17033-0850United StatesAbramson Cancer Center at the University of PennsylvaniaPhiladelphiaPennsylvania19104United StatesFox Chase Cancer CenterPhiladelphiaPennsylvania19111-2497United StatesKimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphiaPennsylvania19107United StatesUPMC Cancer Center at Magee-Womens HospitalPittsburghPennsylvania15213-3180United StatesSoutheast Gynecologic Oncology AssociatesKnoxvilleTennessee37917United StatesVanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashvilleTennessee37232-2516United StatesUniversity of Texas Medical BranchGalvestonTexas77555-0587United StatesCCOP - Scott and White HospitalTempleTexas76508United StatesFletcher Allen Health Care - Medical Center Hospital of Vermont CampusBurlingtonVermont05401United StatesCancer Center at the University of VirginiaCharlottesvilleVirginia22908United StatesFred Hutchinson Cancer Research CenterSeattleWashington98109-1024United StatesMultiCare Regional Cancer Center at Tacoma General HospitalTacomaWashington98405United StatesPretoria Academic HospitalPretoria0001South AfricaUnited StatesSouth Africahttp://cancer.gov/clinicaltrials/GOG-0150Clinical trial summary from the National Cancer Institute's PDQ® databaseWolfson AH, Brady MF, Rocereto T, Mannel RS, Lee YC, Futoran RJ, Cohn DE, Ioffe OB. A gynecologic oncology group randomized phase III trial of whole abdominal irradiation (WAI) vs. cisplatin-ifosfamide and mesna (CIM) as post-surgical therapy in stage I-IV carcinosarcoma (CS) of the uterus. Gynecol Oncol. 2007 Sep 4; [Epub ahead of print]17822748Wolfson AH, Brady MF, Mannel RS, et al.: A Gynecologic Oncology Group randomized trial of whole abdominal irradiation (WAI) vs cisplatin-ifosfamide+mesna (CIM) in optimally debulked stage I-IV carcinosarcoma (CS) of the uterus. [Abstract] J Clin Oncol 24 (Suppl 18): A-5001, 256s, 2006.November 2005February 13, 2009November 1, 1999stage I uterine sarcomastage II uterine sarcomastage III uterine sarcomastage IV uterine sarcomauterine carcinosarcomaNoCarcinosarcomaUterine NeoplasmsSarcomaIsophosphamide mustardCisplatinIfosfamide