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

Alternate Title

Phase I Study of Pelvic or Pelvic Radiotherapy, Cisplatin, and Topotecan in Patients With Locally Advanced Cervical Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	Not specified	NCI	GOG-9913 NCT00054444

Trial Description

Purpose:

Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

This phase I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen.

Eligibility:

Eligibility criteria include the following:

• No more than 2 months since diagnosis
• No previous chemotherapy or radiation therapy for cancer
• No previous therapy for this 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 undergo radiation therapy to the pelvis 5 days a week for 6 weeks. They will also receive an infusion of cisplatin and an infusion of topotecan once a week for 6 weeks.

After finishing treatment, patients will be evaluated periodically for 5 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

Peter Rose, MD, Protocol chair		Ph: 216-444-1712; 800-862-7798 Email: rosep@ccf.org

U.S.A.
Florida
	Miami
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service	Ph:  866-574-5124
			Email: Sylvester@emergingmed.com
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
New Jersey
	Voorhees
	Cancer Institute of New Jersey at Cooper - Voorhees
		Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees	Ph:  856-325-6757
Ohio
	Cleveland
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Peter Rose, MD	Ph:  216-444-1712
	Columbus
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Robert Mannel, MD	Ph:  405-271-8787
	Tulsa
	Cancer Care Associates - Saint Francis Campus
		Robert Mannel, MD	Ph:  405-271-8787

Registry Information
Official Title		A Phase I Study Of Pelvic Radiation Therapy With Concomitant Cisplatin And Weekly Topotecan (IND# 58,13) Chemotherapy In Patients With Cervical Carcinoma And Paraortic Nodal Metastasis As The Only Evidence Of Extrapelvic Disease
Trial Start Date		2007-09-10
Trial Completion Date		2008-09-04 (estimated)
Registered in ClinicalTrials.gov		NCT00054444
Date Submitted to PDQ		2002-12-23
Information Last Verified		2009-11-19
NCI Grant/Contract Number		CA27469

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