Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Advanced Endometrial Cancer

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.

Sex

Female

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

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

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)

• BACKGROUNDMoore KN, Tian C, McMeekin DS, Thigpen JT, Randall ME, Gallion HH. Does the progression-free interval after primary chemotherapy predict survival after salvage chemotherapy in advanced and recurrent endometrial cancer?: a Gynecologic Oncology Group ancillary data analysis. Cancer. 2010 Dec 1;116(23):5407-14. doi: 10.1002/cncr.25480. Epub 2010 Aug 24. PMID 20737572
• BACKGROUNDDiavolitsis V, Boyle J, Singh DK, Small W Jr. The role of adjuvant radiation in endometrial cancer. Oncology (Williston Park). 2009 Apr 15;23(4):342-9. PMID 19476264
• BACKGROUNDModesitt SC, Tian C, Kryscio R, Thigpen JT, Randall ME, Gallion HH, Fleming GF; Gynecologic Oncology Group. Impact of body mass index on treatment outcomes in endometrial cancer patients receiving doxorubicin and cisplatin: a Gynecologic Oncology Group study. Gynecol Oncol. 2007 Apr;105(1):59-65. doi: 10.1016/j.ygyno.2006.10.045. Epub 2006 Dec 5. PMID 17150247
• BACKGROUNDModesitt S, Tian C, Kryscio R, et al.: Impact of body mass index (BMI) on treatment outcomes in advanced or recurrent endometrial cancer patients receiving doxorubicin/cisplatin chemotherapy: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-93, 2006.
• RESULTTewari KS, Filiaci VL, Spirtos NM, Mannel RS, Thigpen JT, Cibull ML, Monk BJ, Randall ME. Association of number of positive nodes and cervical stroma invasion with outcome of advanced endometrial cancer treated with chemotherapy or whole abdominal irradiation: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 Apr;125(1):87-93. doi: 10.1016/j.ygyno.2011.12.414. Epub 2011 Dec 8. PMID 22155678
• RESULTBruner DW, Barsevick A, Tian C, Randall M, Mannel R, Cohn DE, Sorosky J, Spirtos NM. Randomized trial results of quality of life comparing whole abdominal irradiation and combination chemotherapy in advanced endometrial carcinoma: A gynecologic oncology group study. Qual Life Res. 2007 Feb;16(1):89-100. doi: 10.1007/s11136-006-9003-5. Epub 2006 Oct 11.