Radiation Therapy with Temozolomide or PCV Chemotherapy for Anaplastic or Low Grade Glioma
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT00887146
This study is comparing two treatment methods for patients with anaplastic glioma or low grade glioma. It aims to find out if radiation therapy combined with temozolomide is more effective than radiation followed by PCV chemotherapy.
Patient Parameters
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Program Overview
This clinical trial is testing two different treatment approaches for patients with certain types of brain tumors called anaplastic glioma or low grade glioma. The study will compare the effectiveness of radiation therapy combined with the drug temozolomide against radiation therapy followed by a different chemotherapy regimen called PCV. The goal is to see which treatment helps patients live longer without the cancer getting worse.
Description
The study involves patients who have been newly diagnosed with specific types of brain tumors that have a genetic feature called 1p/19q co-deletion. Participants will be randomly assigned to one of two treatment groups. One group will receive radiation therapy along with the drug temozolomide, followed by more temozolomide. The other group will receive radiation therapy followed by PCV chemotherapy.
The main goal is to see if the group receiving temozolomide has a longer period without cancer progression compared to the group receiving PCV. The study will also look at other factors, such as overall survival, quality of life, and any side effects from the treatments. Patients will be monitored regularly after treatment to track their health and any changes in their condition.
Participants will need to provide tissue samples for research purposes and will be asked to complete tests to assess their cognitive function and quality of life. The study will also collect blood samples and imaging scans for future research.
Eligibility Criteria
Inclusion Criteria
- Must be newly diagnosed with anaplastic glioma or high-risk low grade glioma with a specific genetic feature (1p/19q co-deletion and IDH mutation).
- Diagnosis must be confirmed by a qualified laboratory.
- Must be within 3 months of surgical diagnosis, or have had prior surgery for low grade glioma without previous radiation or chemotherapy.
- Must be considered high-risk if diagnosed with low grade glioma, based on age or tumor growth.
- Must have adequate blood counts and organ function as determined by specific tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
- Must be willing to complete cognitive and quality of life assessments.
- Must agree to provide tissue and blood samples for research.
- Must be able to return for follow-up visits and comply with study requirements.
Exclusion Criteria
- Pregnant or nursing women.
- Individuals unwilling to use contraception during and after treatment.
- Previous radiation or chemotherapy for glioma.
- Severe health conditions that could interfere with the study.
- Active infections or serious heart conditions.
- Other active cancers within the past 5 years, except for certain skin or cervical cancers.
- Recent heart attack or heart failure requiring ongoing treatment.
- Recent hepatitis infection or risk of reactivation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Providence Hospital | 36608 | Mobile | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Saint Joseph's Hospital and Medical Center | 85013 | Phoenix | Arizona |
| Arizona Oncology-Deer Valley Center | 85027 | Phoenix | Arizona |
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