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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase III Randomized Study of Pelvic Radiotherapy Versus Vaginal Cuff Brachytherapy, Paclitaxel, and Carboplatin in Patients With High-Risk Stage I or II Endometrial Carcinoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Approved-not yet active 18 and over NCI GOG-0249 GOG-0249, NCT00807768

Trial Description

Purpose:

Radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether pelvic radiation therapy is more effective than vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial cancer.

This randomized phase III trial is studying pelvic radiation therapy to see how well it works compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with high-risk stage I or stage II endometrial cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No more than 12 weeks since undergoing surgery to remove the uterus, ovaries, and fallopian tubes
• No recurrent cancer
• No sarcoma, carcinosarcoma, or leiomyosarcoma of the uterus
• No previous chemotherapy, radiation therapy, hormone therapy, or biological therapy for endometrial cancer
• No previous chemotherapy or radiation therapy for any other cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will undergo radiation therapy to the pelvis 5 days a week for up to 6 weeks. Some patients may also undergo one or two implant radiation therapy treatments.

Patients in group two will undergo one to five implant radiation therapy treatments. Beginning within 3 weeks after starting implant radiation therapy, patients will receive a 3-hour infusion of paclitaxel and a 30- to 60-minute infusion of carboplatin every 3 weeks for up to three courses.

Patients will fill out questionnaires periodically to assess quality of life, side effects, and fatigue.

After finishing treatment, patients will be evaluated periodically for up to 10 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

D. Scott McMeekin, MD, Protocol chair		Ph: 405-271-8707
Marcus Randall, MD, Protocol co-chair		Ph: 859-257-7618

Related Information

PDQ® clinical trial GOG-0210

Registry Information
Official Title		A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed By Paclitaxel/Carboplatin Chemotherapy in Patients with High Risk, Early Stage Endometrial Carcinoma
Trial Start Date		2008-07-01 (estimated)
Trial Completion Date		2013-03-01 (estimated)
Registered in ClinicalTrials.gov		NCT00807768
Date Submitted to PDQ		2008-12-04
Information Last Verified		2008-12-10
NCI Grant/Contract Number		CA27469