Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Anaplastic Astrocytoma

Phase II Trial of Pre-Irradiation Chemotherapy With BCNU, Cisplatin and Oral Etoposide Combined With Radiation Therapy in the Treatment of Grade 3 Astrocytoma (Anaplastic Astrocytoma)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003621

Enrollment

Registered

2004-04-23

Start date

1999-02-28

Completion date

2005-07-31

Last updated

2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytoma

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 more than one drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have newly diagnosed anaplastic astrocytoma.

Detailed description

OBJECTIVES: I. Determine the efficacy of carmustine, cisplatin, and etoposide given prior to and during radiotherapy in patients with anaplastic astrocytoma. II. Assess the toxic effects associated with this regimen in these patients. III. Evaluate this regimen in terms of fatigue, depression, excessive daytime somnolence, and quality of life in these patients. OUTLINE: Patients receive carmustine IV over 1 hour on days 1-3, oral etoposide on days 1-21 and 29-49, and cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8 weeks for 3 courses. Patients receive radiotherapy concurrently with the third course of chemotherapy. Quality of life is assessed every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients are followed every 3 months for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 20 months.

Interventions

DRUGcarmustine

DRUGcisplatin

DRUGetoposide

RADIATIONradiation therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, anaplastic astrocytoma No oligodendrogliomas or oligoastrocytomas PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3500/mm3 Platelet count at least 130,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 0.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled infection No concurrent malignant disease or major medical problem except superficial skin cancers PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 5 years since prior chemotherapy Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: At least 5 years since prior radiotherapy Surgery: Not specified

Design outcomes

Primary

Measure	Time frame
overall survival	Up to 10 years

Secondary

Measure	Time frame
quality of life	Up to 10 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026