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Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma
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.
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Start Date
July 1, 2000
Primary Completion Date
July 1, 2009
Last Updated
December 31, 2014
31
ACTUAL participants
Doxorubicin Hydrochloride
DRUG
Cisplatin
DRUG
Radiation Therapy
RADIATION
Lead Sponsor
Gynecologic Oncology Group
Collaborators
NCT07077876
NCT03660826
Data Source & Attribution
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