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 which treatment regimen is more effective for endometrial cancer.

PURPOSE: Randomized phase III trial to compare radiation therapy with chemotherapy in treating patients who have advanced endometrial cancer.

Condition	Treatment or Intervention	Phase
stage III endometrial cancer stage IV endometrial cancer endometrial clear cell carcinoma endometrial adenosquamous cell carcinoma endometrial adenocarcinoma endometrial papillary carcinoma psychosocial effects/treatment endometrial adenoacanthoma	Drug: cisplatin  Drug: doxorubicin	Phase III

Further Study Details: 

OBJECTIVES: I. Compare overall survival, progression-free interval, and patterns of failure of maximally debulked patients with stage III/IV endometrial carcinoma treated with whole-abdominal irradiation vs. doxorubicin/cisplatin.

II. Compare the incidence and type of acute and late adverse events observed with these two treatment regimens.

III. Compare changes in fatigue, elimination, and neurologic impairment that impact on quality of life in patients treated with these two regimens.

IV. Assess the difference in short-term versus long-term impact on quality of life between the two treatment groups.

V. Compare quality-of-life outcomes over time between these two treatment groups.

PROTOCOL OUTLINE: Randomized study.

Arm I: Radiotherapy. Whole-abdominal irradiation using equipment with photon energies ranging from 6 to 25 MV.

Arm II: 2-Drug Combination Chemotherapy. Doxorubicin, DOX, NSC-123127; Cisplatin, CDDP, NSC-119875.

PROJECTED ACCRUAL: It is anticipated that 355 patients will be entered over 7.4 years.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Pathological stage III/IV endometrial carcinoma of any histology (including clear cell and serous papillary carcinomas)
• The following extent of disease eligible: Positive adnexa; Tumor invading the serosa; Positive pelvic nodes; Positive para-aortic nodes; Involvement of the bowel mucosa; Intra-abdominal metastases; Positive pelvic washings; Vaginal involvement within the radiotherapy field
• Hysterectomy and bilateral salpingo-oophorectomy (BSO) required with residual tumor not greater than 2 cm at any site; Selective pelvic and para-aortic lymph node sampling optional for patients with stage III/IV disease by other criteria; If para-aortic nodes are positive, scalene nodes must be negative on biopsy and chest CT must be negative for intrathoracic disease
• The following disease conditions exclude: Parenchymal liver metastasis; Lung metastasis; Positive inguinal nodes; Positive scalene nodes; Recurrent disease
• Protocol therapy must begin within 8 weeks after surgery

--Prior/Concurrent Therapy--

• Biologic therapy: No prior biologic therapy
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Prior progestational agents allowed; No other prior endocrine therapy
• Radiotherapy: No prior pelvic or abdominal radiotherapy
• Surgery: Hysterectomy and BSO required; Pelvic and para-aortic lymph node sampling optional (see Disease Characteristics)

--Patient Characteristics--

• Age: Not specified
• Performance status: GOG 0-3
• Hematopoietic: WBC at least 3,000/mm3; Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 1.5 times normal; AST no greater than 3 times normal
• Renal: Creatinine no greater than 2.0 mg/dL
• Cardiovascular: Left ventricular ejection fraction normal
• Other: No past or concomitant malignancy other than nonmelanomatous skin cancer

Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States
Arizona
      CCOP - Greater Phoenix, Phoenix,  Arizona,  85006-2726,  United States
California
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      Stanford University Medical Center, Stanford,  California,  94305-5408,  United States
      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States
      Women's Cancer Center, Palo Alto,  California,  94304,  United States
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States
District of Columbia
      Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington,  District of Columbia,  20007,  United States
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612,  United States
Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States
Illinois
      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5265,  United States
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States
Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States
Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21287,  United States
Massachusetts
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States
Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
New Jersey
      Cooper Hospital/University Medical Center, Camden,  New Jersey,  08103,  United States
New York
      Cancer Center of Albany Medical Center, Albany,  New York,  12208,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      State University of New York Health Science Center at Brooklyn, Brooklyn,  New York,  11203,  United States
      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11790-9832,  United States
      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States
North Carolina
      Brookview Research, Inc., Winston Salem,  North Carolina,  27103,  United States
      Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157-1082,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210,  United States
      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45219,  United States
      Cleveland Clinic Cancer Center, Cleveland,  Ohio,  44195,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107,  United States
      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States
      Pennsylvania Hospital, Philadelphia,  Pennsylvania,  19107,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104,  United States
South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States
      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States
Tennessee
      CCOP - Baptist Cancer Institute, Memphis,  Tennessee,  38117,  United States
Texas
      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States
Virginia
      Cancer Center, University of Virginia HSC, Charlottesville,  Virginia,  22908,  United States
Washington
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States
      University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States

Study chairs or principal investigators

Marcus E. Randall,  Study Chair,  Gynecologic Oncology Group   

Study ID Numbers:  CDR0000077572; GOG-122
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002493
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08