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

Alternate Title

Phase III Randomized Study of Radical Hysterectomy and Tailored Chemoradiotherapy Versus Primary Chemoradiotherapy in Patients With Stage IB2 Carcinoma of the Cervix

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 and over	NCI	GOG-0201 NCT00054067

Trial Description

Purpose:

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 regimen of radiation therapy combined with chemotherapy, with or without surgery, is more effective in treating early cancer of the cervix.

Randomized phase III trial to compare the effectiveness of surgery followed by different regimens of radiation therapy and chemotherapy with that of chemotherapy and radiation therapy alone in treating patients who have stage I cancer of the cervix.

Eligibility:

• At least 18 years old
• No previous treatment for this cancer
• No previous chemotherapy, radiation therapy, or hysterectomy
• 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 to one of two groups. Patients in group one will undergo laparotomy followed by surgery to remove the uterus, cervix, and lymph nodes in the pelvis. During surgery, doctors will determine whether it is appropriate to continue the hysterectomy or stop surgery.

• If the uterus, cervix, and lymph nodes are not removed in surgery, patients will receive chemotherapy, radiation therapy to the pelvis, and internal radiation therapy, or they will receive no treatment.
• If the uterus, cervix, and lymph nodes are removed in surgery, patients will receive chemotherapy and radiation therapy to the pelvis or they will receive no treatment.

Patients in group two will undergo radiation therapy to the pelvis, internal radiation therapy, and chemotherapy.

In all groups, quality of life will be assessed periodically. Patients will be evaluated every 3 months for 2 years, every 6 months for 3 years, and once a year thereafter.

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

Registry Information
Official Title		Treatment of Patients with Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation
Trial Start Date		2003-02-06
Registered in ClinicalTrials.gov		NCT00054067
Date Submitted to PDQ		2002-12-16
Information Last Verified		2004-09-09
NCI Grant/Contract Number		U10-CA27469

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