Clinical trial · Interventional
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase II Trial of Pre-irradiation Chemotherapy With BCNU, Cisplatin and Oral Etoposide Combined With Radiation Therapy in the Treatment of Grade 4 Astrocytoma (Glioblastoma)
NCT00003996CI-TRIAL-00025033completedPhase 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: 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 chemotherapy 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 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| chemotherapy | Drug | Chemotherapy | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- chemotherapy + carmustine + etoposide + cisplatin + radiation
- description
- Patients receive pre-irradiation chemotherapy consisting of carmustine IV over 1 hour on days 1-3 and oral etoposide on days 1-21 and 29-49 immediately followed by cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8 weeks for 2 courses. Patients receive concurrent cranial radiotherapy daily over 8 weeks during course 2. Patients then receive carmustine IV over 1-2 hours every 8 weeks for 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before the study, prior to each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients are followed every 4 months for 1 year, every 6 months for 4 years, annually for 5 years, and then for survival.
- interventionNames
- Drug: carmustine
- Drug: chemotherapy
- Drug: cisplatin
- Drug: etoposide
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- Up to 10 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed glioblastoma multiforme No oligodendrogliomas or oligoastrocytomas PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/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 above ULN Other: No uncontrolled infection No other major medical conditions No other concurrent malignancy except superficial skin cancers Must be able to read English (quality of life assessment only) No other problem that may preclude quality of life assessment Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Concurrent steroids allowed Radiotherapy: No prior radiotherapy Surgery: Not specified
References
Publications (2)
- RESULTJaeckle K, Ballman K, O'Fallon J, et al.: Response to pre-radiation chemotherapy as a predictor of survival in patients with newly diagnosed malignant astrocytoma: a North Central Cancer Treatment Group (NCCTG) study. [Abstract] Neuro-Oncology 6 (4): TA-26, 376, 2004.
- RESULTJaeckle K, Ballman K, Uhm J, et al.: Relationship of administration of enzyme-inducing anticonvulsants (EIAC) to survival in patients with glioblastoma: a North Central Cancer Treatment Group (NCCTG) study. [Abstract] Neuro-Oncology 6 (4): TA-27, 376, 2004.