drugset / Trial / NCT00002620
Radiation Therapy in Treating Patients With Brain Cancer
RandomizedTreatment
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with anaplastic astrocytomas. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in treating patients with anaplastic astrocytomas.
Timeline
- Start
- 1994-11
- Primary completion
- 2000-06
- Completion
- —
Outcome
Missed primary endpoint
paper On intent-to-treat analysis, no statistically significant differences in OS (p=0.111) and PFS (p=0.087) were observed PMID 18248979 ↗
paper No statistically significant improvement in survival was observed after BCNU/DBD adjuvant chemotherapy in AA patients. PMID 18248979 ↗
Publications
- Results Hildebrand J, Gorlia T, Kros JM, Afra D, Frenay M, Omuro A, Stupp R, Lacombe D, Allgeier A, van den Bent MJ; EORTC Brain Tumour Group investigators. Adjuvant dibromodulcitol and BCNU chemotherapy in anaplastic astrocytoma: results of a randomised European Organisation for Research and Treatment of Cancer phase III study (EORTC study 26882). Eur J Cancer. 2008 Jun;44(9):1210-6. doi: 10.1016/j.ejca.2007.12.005. Epub 2008 Jan 14.
- Results Hildebrand J, Sahmoud T, Mignolet F, Brucher JM, Afra D. Adjuvant therapy with dibromodulcitol and BCNU increases survival of adults with malignant gliomas. EORTC Brain Tumor Group. Neurology. 1994 Aug;44(8):1479-83. doi: 10.1212/wnl.44.8.1479.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | carmustine | Small molecule | 150 mg/m2 | — |
| Subject | mitolactol | Small molecule | 1000 mg/m2 | — |