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.
|Endometrial Cancer Psychosocial Effects of Cancer and Its Treatment||Drug: cisplatin Drug: doxorubicin hydrochloride Radiation: low-LET photon therapy||Phase 3|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||WHOLE ABDOMINAL RADIOTHERAPY VERSUS CIRCADIAN-TIMED COMBINATION DOXORUBICIN-CISPLATIN CHEMOTHERAPY IN ADVANCED ENDOMETRIAL CARCINOMA -- PHASE III|
|Study Start Date:||May 1992|
|Primary Completion Date:||April 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002493
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|Study Chair:||Marcus E. Randall, MD||Indiana University Melvin and Bren Simon Cancer Center|