Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pre-RT temozolomide, RT plus temozolomide neoadjuvant therapy Pre-radiation therapy (RT) temozolomide, RT plus temozolomide Pre-RT temozolomide, RT plus temozolomide radiation therapy Pre-radiation therapy (RT) temozolomide, RT plus temozolomide Pre-RT temozolomide, RT plus temozolomide temozolomide Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
- Primary Outcome Measures
Name Time Method Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression) From start of treatment to 6 months
- Secondary Outcome Measures
Name Time Method Overall Survival From registration to date of death or last follow-up
Trial Locations
- Locations (39)
Mercy Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
University of Miami Sylvester Cancer Center
🇺🇸Miami, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Shands Cancer Center at the University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Wayne Memorial Hospital, Inc.
🇺🇸Goldsboro, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Mount Carmel West Hospital
🇺🇸Columbus, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
🇺🇸Omaha, Nebraska, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Anderson Area Cancer Center
🇺🇸Anderson, South Carolina, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States