Radiation Therapy and Tamoxifen in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme

Phase 2 Completed 77 enrolled Radiation Therapy Oncology Group National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as tamoxifen may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with tamoxifen in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.

Timeline

Start: 2000-12
Primary completion: 2003-10
Completion: —

Outcome

Missed primary endpoint

paper After controlling for RPA class IV, the MST was 11.3 months, which compares to the historical RPA control of 11.3 months (P = 0.37). PMID 16443947 ↗

paper The results obtained do not exhibit a substantial advance over those of previous studies with various XRT/drug doublets, including BCNU. PMID 16443947 ↗

Publications

Results Robins HI, Won M, Seiferheld WF, Schultz CJ, Choucair AK, Brachman DG, Demas WF, Mehta MP. Phase 2 trial of radiation plus high-dose tamoxifen for glioblastoma multiforme: RTOG protocol BR-0021. Neuro Oncol. 2006 Jan;8(1):47-52. doi: 10.1215/S1522851705000311.
Results Robins HI, Won M, Schultz C, et al.: A phase II trial of conventional radiation therapy (XRT) plus high dose tamoxifen (TAM) for the treatment of supratentorial glioblastoma multiforme (GBM): RTOG protocol BR-0021. [Abstract] J Clin Oncol 22 (Suppl 14): A-1529, 114s, 2004.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tamoxifen	Small molecule	80 mg/m2	Oral