MedPath

Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas

Phase 2
Completed
Conditions
Brain and Central Nervous System Tumors
Interventions
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Registration Number
NCT00033280
Lead Sponsor
Radiation Therapy Oncology Group
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas.

Detailed Description

OBJECTIVES:

* Determine the rate of progression in patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and concurrent temozolomide with radiotherapy.

* Determine the toxicity of this regimen in these patients.

* Determine the survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to response to neoadjuvant temozolomide (stable disease or partial response (PR) vs complete response (CR)).

Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive 2 courses beyond CR or PR.

Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide daily for 42 days concurrently with radiotherapy.

Patients with CR after completion of neoadjuvant temozolomide undergo observation.

Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
42
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Pre-RT temozolomide, RT plus temozolomideneoadjuvant therapyPre-radiation therapy (RT) temozolomide, RT plus temozolomide
Pre-RT temozolomide, RT plus temozolomideradiation therapyPre-radiation therapy (RT) temozolomide, RT plus temozolomide
Pre-RT temozolomide, RT plus temozolomidetemozolomidePre-radiation therapy (RT) temozolomide, RT plus temozolomide
Primary Outcome Measures
NameTimeMethod
Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression)From start of treatment to 6 months
Secondary Outcome Measures
NameTimeMethod
Overall SurvivalFrom registration to date of death or last follow-up

Trial Locations

Locations (39)

Mobile Infirmary Medical Center

🇺🇸

Mobile, Alabama, United States

Foundation for Cancer Research and Education

🇺🇸

Phoenix, Arizona, United States

CCOP - Mayo Clinic Scottsdale Oncology Program

🇺🇸

Scottsdale, Arizona, United States

Shands Cancer Center at the University of Florida Health Science Center

🇺🇸

Gainesville, Florida, United States

Mayo Clinic

🇺🇸

Jacksonville, Florida, United States

University of Miami Sylvester Cancer Center

🇺🇸

Miami, Florida, United States

Baptist Hospital of Miami

🇺🇸

Miami, Florida, United States

Mayo Clinic Cancer Center

🇺🇸

Rochester, Minnesota, United States

CCOP - Kansas City

🇺🇸

Kansas City, Missouri, United States

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

🇺🇸

Omaha, Nebraska, United States

Scroll for more (29 remaining)
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.