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

October 21, 2020 updated by: Radiation Therapy Oncology Group

A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36652-2144
        • Mobile Infirmary Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Foundation for Cancer Research and Education
      • Scottsdale, Arizona, United States, 85259-5404
        • CCOP - Mayo Clinic Scottsdale Oncology Program
    • Florida
      • Gainesville, Florida, United States, 32610-0385
        • Shands Cancer Center at the University of Florida Health Science Center
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Cancer Center
      • Miami, Florida, United States, 33256-2110
        • Baptist Hospital of Miami
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
    • Nebraska
      • Omaha, Nebraska, United States, 68114-4199
        • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
    • New Jersey
      • Long Branch, New Jersey, United States, 07740-6395
        • Monmouth Medical Center
    • North Carolina
      • Goldsboro, North Carolina, United States, 27533
        • Wayne Memorial Hospital, Inc.
      • Rutherfordton, North Carolina, United States, 28139-0000
        • Rutherford Hospital
      • Winston-Salem, North Carolina, United States, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Akron, Ohio, United States, 44304
        • Akron City Hospital
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
      • Columbus, Ohio, United States, 43222
        • Mount Carmel West Hospital
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Marietta, Ohio, United States, 45750-1635
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Newark, Ohio, United States, 43055-2899
        • Licking Memorial Hospital
      • Toledo, Ohio, United States, 43623-3456
        • CCOP - Toledo Community Hospital
    • Oregon
      • Portland, Oregon, United States, 97225
        • CCOP - Columbia River Oncology Program
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • Mercy Hospital of Pittsburgh
    • South Carolina
      • Anderson, South Carolina, United States, 29621-5705
        • Anderson Area Cancer Center
    • Utah
      • Murray, Utah, United States, 84107
        • Cottonwood Hospital Medical Center
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, United States, 84770
        • Dixie Regional Medical Center
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health Sciences Center
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Washington
      • Seattle, Washington, United States, 98195-6043
        • University Cancer Center at University of Washington Medical Center
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Comprehensive Cancer Center
      • Marshfield, Wisconsin, United States, 54449
        • CCOP - Marshfield Clinic Research Foundation
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed supratentorial pure or mixed anaplastic oligodendroglioma

    • Unifocal or multifocal disease
    • Prior suspected or proven low-grade glioma eligible provided biopsy reveals pure or mixed anaplastic oligodendroglioma that has not been previously treated with radiotherapy and/or chemotherapy
  • No equivocal oligodendroglial element
  • No tumors predominantly located in the posterior fossa (i.e., brainstem or cerebellum)
  • No spinal cord tumors
  • No evidence of spinal drop metastasis or spread to noncontiguous meninges

PATIENT CHARACTERISTICS:

Age:

  • 18 to 65

Performance status:

  • Zubrod 0-1

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin no greater than 2 times normal
  • Aspartate aminotransferase (AST) no greater than 3 times normal
  • Alkaline phosphatase no greater than 2 times normal

Renal:

  • Creatinine no greater than 1.5 times normal

Other:

  • No active infection
  • No other medical problems that would preclude study participation
  • No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No prior chemotherapy for this malignancy
  • No prior temozolomide

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy to the brain, head, or neck

Surgery:

  • At least 14 days since prior surgery requiring general anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-RT temozolomide, RT plus temozolomide
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
Radiation: radiation therapy
Drug: temozolomide
Procedure: neoadjuvant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression)
Time Frame: From start of treatment to 6 months
From start of treatment to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From registration to date of death or last follow-up
From registration to date of death or last follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)
NRG Oncology

Investigators

  • Study Chair: Michael A. Vogelbaum, MD, PhD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

May 14, 2018

Study Registration Dates

First Submitted

April 9, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG-BR-0131
  • CDR0000069270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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