Clinical Trial: Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase III Randomized Study (Phase I Closed) of Radiation Therapy and Temozolomide Versus Radiation Therapy and Nitrosourea for Anaplastic Astrocytoma And Mixed Anaplastic Oligo

Brief Summary:

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

PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared to radiation therapy and carmustine or lomustine in treating patients with anaplastic astrocytoma or mixed gliomas.


Detailed Summary:

OBJECTIVES:

  • Compare the overall survival and time to tumor progression in patients with anaplastic astrocytoma or mixed gliomas treated with radiotherapy combined with temozolomide vs carmustine or lomustine vs temozolomide and carmustine (arm discontinued as of 8/15/02).
  • Compare the relative toxic effects of these regimens in these patients.
  • Correlate molecular analyses with overall survival and time to tumor progression in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), Karnofsky performance status (60-80% vs 90-100%), and prior surgery (biopsy only vs resection).

Phase I (closed as of 8/15/02)

  • Prior to initiating the randomization to 1 of 3 treatment arms in phase III, 15 patients are accrued to arm III. If 2 or more of the first 15 patients experience grade 3 or worse pulmonary toxicity OR if 5 or more of the first 15 patients experience grade 4-5 thrombocytopenia/neutropenia, then arm III treatment is discontinued.

Phase III

  • Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive oral temozolomide on days 1-5 of the first week of radiotherapy. Chemotherapy repeats every 4 weeks for a total of 12 courses.

    • Sponsor: Radiation Therapy Oncology Group

      Current Primary Outcome: Overall survival (OS) [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after 155 deaths have been reported. ]

      Original Primary Outcome:

      Current Secondary Outcome:

      • Time to tumor progression (TTP) [ Time Frame: From randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis. ]
      • Toxicity [ Time Frame: From start of treatment to end of follow-up. Analysis occurs at the same time as the primary outcome analysis. ]
      • Correlation of molecular analyses with OS and TTP [ Time Frame: Molecular markers are centrally reviewed after randomization. ]


      Original Secondary Outcome:

      Information By: Radiation Therapy Oncology Group

      Dates:
      Date Received: January 28, 2000
      Date Started: June 2000
      Date Completion:
      Last Updated: September 28, 2016
      Last Verified: September 2016