Clinical trial · Interventional
Radiation Therapy and Tamoxifen in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme
A Phase II Trial of High Dose Tamoxifen For The Treatment of Newly Diagnosed Supratentorial Glioblastoma Multiforme (GBM)
NCT00006388CI-TRIAL-00047800completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation plus Tamoxifen
- interventionNames
- Drug: tamoxifen citrate
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven newly diagnosed, supratentorial glioblastoma multiforme (with areas of necrosis) Diagnosis must be made by surgical biopsy or excision within the past 5 weeks No recurrent malignant gliomas No metastases below the tentorium or beyond the cranial vault PATIENT CHARACTERISTICS: Age: Adult Performance status: Karnofsky 70-100% OR Zubrod 0-1 Life expectancy: At least 8 weeks Hematopoietic: Hemoglobin at least 10 g/dL (transfusion allowed) Hematocrit at least 30% (transfusion allowed) Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) no greater than 2 times normal Renal: Blood urea nitrogen no greater than 25 mg/dL Creatinine no greater than 1.5 mg/dL Cardiovascular: No active thrombophlebitis Other: Recovered from any postoperative infection or other complications No major medical illnesses or psychiatric impairments that would preclude study participation No active connective tissue disorder, such as lupus or scleroderma No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix or bladder No prior endometrial cancer or atypical endometrial hyperplasia No AIDS Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 12 months since prior tamoxifen Radiotherapy: See Disease Characteristics No prior radiotherapy to head or neck Surgery: See Disease Characteristics Recovered from prior surgery
References
Publications (2)
- RESULTRobins 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. PMID 16443947
- RESULTRobins 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.