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Tumor Resection and Gliadel® Wafers, Followed by Temodar® With Standard Radiation or GammaKnife® for New GBM

NCT02085304 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-04-19

No results posted yet for this study

Summary

A glioblastoma (GBM) is the most common malignant primary brain tumor, yet it is not easy to control. Recent studies show that survival improves for patients who get aggressive surgery to remove a tumor before starting radiation (RT) and chemotherapy (chemo) treatment. Surgery, RT and chemo are part of regular cancer care for GBM. RT is usually done in daily doses 5 days a week over about 6 weeks. Beams of radiation are aimed at the tumor site plus some of the normal brain tissue around the tumor area. GammaKnife® (GK) radiosurgery also delivers radiation but in a larger dose over one day. GK sends beams to a precise target (tumor location) and very little normal brain tissue that is nearby. This study will compare GK treatment to the usual RT treatment after surgery, and with chemo.

We want to know:

* How well each treatment keeps the tumor from growing back.
* What the effects (good and bad) of the treatments are.
* How you rate your quality of life.
* How the treatment affects your ability to think, understand, reason, and remember.
* How you rate your ability to think, understand, reason, and remember.
* If using a certain type of MRI scan can show the difference between new tumor growth and changes caused by treatment.
* If certain features found in tumor cells can help doctors predict how tumors will respond to treatment.

Conditions

Interventions

PROCEDURE

Gross total resection and Gliadel(R) wafers implanted

Complete removal of tumor and implant of Gliadel(R) wafers that are small, dime-sized wafers designed to deliver the chemo drug, carmustine, directly into the cavity made when the brain tumor was removed.

RADIATION

GammaKnife(R) stereotactic Radiosurgery

GammaKnife® (GK) radiosurgery dose of 15 Gy in one fraction to the resection cavity margin

RADIATION

Standard fractionated radiation therapy

standard fractionated RT of 60 Gy in 30 fractions (over approximately six weeks)

DRUG

Temozolomide

temozolomide 75 mg/m2 daily for 42 days, will be administered to all patients beginning within 24 hours of GK/RT initiation as is routine clinical care. There will be a one month drug holiday following the 42 days before adjuvant chemotherapy begins. Adjuvant temozolomide administered 5 days monthly at 150-200 mg/m2/day will be administered for 12 months as is routine clinical care.

Sponsors & Collaborators

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • Kris A Smith, MD · Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-07
Primary Completion
2015-05-30
Completion
2018-05-29

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02085304 on ClinicalTrials.gov