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

 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.
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)