Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

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

Alternate Title

Phase III Randomized Study of High-Dose Sequential Chemotherapy Versus Standard Chemotherapy in Patients With Optimally Debulked Stage III or IV Ovarian Epithelial Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 65	Other	EBMT-HIDOC-EIS EBMT-OVCAT, EU-99040, NCT00004921

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is most effective for ovarian epithelial cancer.

This randomized phase III trial is studying high- dose chemotherapy to see how well it works compared to standard chemotherapy in treating patients with stage III or stage IV ovarian epithelial cancer that has been removed during surgery.

Eligibility:

Eligibility criteria include the following:

• 18-65 years old
• No more than 6 weeks since surgery to remove the tumor
• No previous chemotherapy
• 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 receive five courses of high-dose combination chemotherapy plus peripheral stem cell transplantation. Treatment may be repeated every 3-4 weeks.

Patients in group two will receive standard combination chemotherapy every 4 weeks for six courses.

Quality of life will be assessed before treatment and periodically after treatment. Patients will receive follow-up evaluations 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

EBMT Solid Tumors Working Party

Jonathan Ledermann, MD, Protocol chair		Ph: 44-20-7679-8040 Email: j.ledermann@ctc.ucl.ac.uk

Registry Information
Official Title		A Randomized Phase III Trial of Sequential High Dose Chemotherapy or Standard Chemotherapy for Optimally Debulked FIGO Stage III and IV Ovarian Cancer
Trial Start Date		1998-09-01
Registered in ClinicalTrials.gov		NCT00004921
Date Submitted to PDQ		2000-01-13
Information Last Verified		2002-07-02

Back to Top