Treatment of Resectable Malignant Brain Tumors

NCT00415467 | Terminated Phase 4

• 1 other identifier: 2003-0942
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this study are to evaluate each of the following items:

1. 1.Time to recurrence in patients receiving brachytherapy with the GliaSite RTS
2. 2.Overall survival (OS) in patients with malignant brain tumors who are undergoing surgical resection and brachytherapy treatment with the GliaSite® Radiation Therapy System (RTS).
3. 3.Incidence of serious adverse events in patients treated with GliaSite RTS

Conditions

Brain Tumor

Keywords

Brain Tumor; Radiation Therapy System; GliaSite RTS

Outcome Measures

Primary Outcomes (1)

• Time to Recurrence of Brain Tumor (anywhere in brain)

  Time to recurrence of brain tumor determined for each patient from the time at the end date of brachytherapy with the GliaSite RTS until the date of documented brain tumor recurrence.

  From brachytherapy to assessments at 1 and 3 months after brachytherapy then every 3 months after that or until documented brain tumor recurrence.

Secondary Outcomes (1)

• Overall Patient Survival

  Time from completion of the GliaSite procedure to death by any cause (time in months).

Study Arms (1)

GliaSite Radiation Therapy System (RTS)

EXPERIMENTAL

Surgical removal of brain tumor followed by GliaSite RTS targeted brachytherapy to the specific brain tumor site

Device: GliaSite Radiation Therapy System

Interventions

GliaSite Radiation Therapy System DEVICE

Radiation delivery system that provides brachytherapy targeted to a specific site in the brain, to see its effects to the surrounding area where the tumor was located.

Also known as: GliaSite RTS

GliaSite Radiation Therapy System (RTS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have histologically proven malignant brain tumor
• Patient must be a candidate for surgical resection of the tumor mass.
• Patient must not be pregnant or breast-feeding. All patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods to avoid conception.
• Patient must sign informed consent form

You may not qualify if:

• \. Serious concurrent infection or medical illness which could jeopardize the ability of the patient to receive the GliaSite catheter with reasonable safety.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anita Mahajan, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2006
• First Posted: December 25, 2006
• Study Start: January 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: July 1, 2008
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

US (1)