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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 Boron Neutron Capture Therapy and Borocaptate Sodium Following Craniotomy with Gross Total Resection in Patients With Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	50 and over	Other	EORTC-11961 NCT00004015

Trial Description

Purpose:

Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.

This phase I trial is studying the side effects and best dose of boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery.

Eligibility:

Eligibility criteria include the following:

• At least 50 years old
• No previous brain cancer
• No previous brain surgery except for glioblastoma
• No previous biological therapy, chemotherapy, or radiation therapy for glioblastoma multiforme
• No previous hormone therapy other than corticosteroids for glioblastoma multiforme
• No previous radiation therapy to the head and neck
• 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:

Within 6 weeks after surgery, patients will receive a drug containing the element boron followed 12-18 hours later by neutron radiation therapy. Treatment will be repeated once a day for 4 days. Patients will receive follow-up evaluations once a week for 4 weeks, once a month for 2 months, every 6 weeks for 15 months, and every 3 months 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

European Organization for Research and Treatment of Cancer

Wolfgang Sauerwein, MD, PhD, Study coordinator		Ph: 49-201-723-2052 Email: w.sauerwein@uni-essen.de

Registry Information
Official Title		Postoperative Treatment of Glioblastoma with BNCT at the Petten Irradiation Facility
Trial Start Date		2002-06-14
Registered in ClinicalTrials.gov		NCT00004015
Date Submitted to PDQ		1999-07-29
Information Last Verified		2006-05-02

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