Clinical trial · Interventional
Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme
A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme
NCT00006386CI-TRIAL-00047797completedPhase 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 used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by carmustine in treating patients who have 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- External beam radiotherapy with stereotactic boost
- description
- External beam radiotherapy (EBXRT): 50 Gy in 25 daily fractions of 2 Gy. Stereotactic radiotherapy (SRT) boost: 4 treatments of 5 or 7 Gy, once per week during weeks 3-6. Patients will not receive EBXRT on the SRT treatment days.
- interventionNames
- Drug: carmustine
- Radiation: radiation therapy
- Radiation: stereotactic radiosurgery
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.
Secondary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed supratentorial glioblastoma multiforme by surgical biopsy or resection within 5 weeks of study * Postoperative residual contrast enhancing tumor and resection tumor cavity together no greater than 60 mm in maximum diameter * No well-differentiated or anaplastic astrocytomas or multifocal glioma * No tumors originating in the brainstem * No residual tumor within 10 mm of optic chiasm * No recurrent glioblastoma multiforme PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Hemoglobin greater than 9 g/dL * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * Serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) less than 2 times normal Renal: * Creatinine less than 1.8 mg/dL * Blood urea nitrogen (BUN) less than 30 mg/dL Pulmonary: * Chest x-ray normal OR * Diffusion capacity of lung for carbon monoxide (DLCO) greater than 60% predicted Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Neurologic functional status 0-3 * No other prior malignancy within the past 5 years except carcinoma in situ of the cervix or bladder, ductal carcinoma in situ of the breast, or nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Concurrent steroids allowed Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * Concurrent anticonvulsants allowed
References
Publications (1)
- RESULTCardinale R, Won M, Choucair A, Gillin M, Chakravarti A, Schultz C, Souhami L, Chen A, Pham H, Mehta M. A phase II trial of accelerated radiotherapy using weekly stereotactic conformal boost for supratentorial glioblastoma multiforme: RTOG 0023. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1422-8. doi: 10.1016/j.ijrobp.2006.02.042. Epub 2006 Jun 5. PMID 16750317