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

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

DRUG

BCNU 80mg/m2

BCNU 80 mg/m2 will be administered as an intravenous infusion on days 1, 2, and 3 of the first week of radiotherapy and on days 56, 57, and 58, then every eight weeks for four more cycles for a total of 6 cycles (maximum BCNU dose 1440 mg/m2).

DRUG

TMZ 200mg/m2

200 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat every 28 days for a total of 12 cycles.

RADIATION

radiation therapy

1.8 Gy fractions (to isocenter), 1 fraction per day, 5 days per week to a dose of 59.4 Gy in 33 fractions.

DRUG

CCNU

CCNU at 130 mg/m2 orally every 8 weeks for a total of 6 cycles. Administered on day 1 of the first week of radiotherapy and on day 56, then administered every 8 weeks for four more cycles for a total of 6 cycles.

DRUG

BCNU 150mg/m2

BCNU 150 mg/m2 will be administered as an intravenous infusion on day 5 of radiotherapy, and it will be repeated every eight weeks for a total of six cycles (maximum total BCNU dose 900 mg/m2).

DRUG

BCNU 200mg/m2

BCNU 200 mg/m2 will be administered as an intravenous infusion on day 1 of radiotherapy and will be repeated every six weeks for a total of 6 cycles (maximum BCNU dose 1200 mg/m2).

DRUG

TMZ 150mg/m2 six 6-week cycles

150 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat for a total of six 6-week cycles

DRUG

TMZ 150mg/m2 six 8-week cycles

150 mg/m2 orally on days 1-5 of the first week of radiotherapy. Repeat for a total of six 8-week cycles

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• North Central Cancer Treatment Group

  collaborator NETWORK

• Eastern Cooperative Oncology Group

  collaborator NETWORK

• NRG Oncology

  collaborator OTHER

• Radiation Therapy Oncology Group

  lead NETWORK

Principal Investigators

• Susan M. Chang, MD · University of California, San Francisco

• Kurt A. Jaeckle, MD · Mayo Clinic

• Peter Bushunow, MD · Lipson Cancer and Blood Center at Rochester General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-06-30

Primary Completion

2015-02-01

Completion

2018-05-14

Countries

• United States

Study Locations