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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

Endometrial Adenocarcinoma Clinical Trial

Official title:
Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma

Clinical Trial Summary

Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

Clinical Trial Description

OBJECTIVES:

I. Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer.

II. Determine the acute and chronic toxic effects, in particular, severe and life-threatening gastrointestinal, hepatic, and hematologic toxic effects, of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 21-53 patients will be accrued for this study within 3.5 years. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00005830
Study type Interventional
Source Gynecologic Oncology Group
Contact
Status Completed
Phase Phase 1
Start date July 2000
View Details
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