Clinical trial · Interventional
Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme
Phase I/II Radiation Dose Escalation Study Applying Conformal Radiation Therapy in Supratentorial Glioblastoma Multiforme
NCT00003417CI-TRIAL-00019797completedPhase 1 / Phase 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. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy that has been planned with a computer plus chemotherapy in treating patients who have 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 |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme with areas of necrosis as diagnosed by surgical biopsy or subtotal excision * Supratentorial tumor * Gross measurable residual disease * No well-differentiated or anaplastic astrocytoma, multifocal glioma, or recurrent glioblastoma multiforme * Therapy must begin within 5 weeks after surgery but within 1 week after registration * CT or MRI scan preoperatively and MRI postoperatively prior to initiation of radiotherapy * If undergoing a stereotactic-guided needle biopsy, not required to repeat MRI after procedure if the prebiopsy MRI is suitable for treatment planning * Prior complete surgical resection of tumor allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin no greater than 2 mg/dL * SGPT (serum glutamate pyruvate transaminase) or SGOT (serum glutamic oxaloacetic transaminase) no greater than 2 times normal Renal: * BUN (blood urea nitrogen) no greater than 30 mg/dL * Creatinine no greater than 1.8 mg/dL Pulmonary: * Normal chest x-ray OR * DLCO (carbon monoxide diffusing capacity) at least 60% predicted Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No other 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 * Neurologic functional status 0-3 * No major medical illness or psychiatric impairments that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to head or neck Surgery: * See Disease Characteristics
References
Publications (3)
- RESULTCorn BW, Wang M, Fox S, Michalski J, Purdy J, Simpson J, Kresl J, Curran WJ Jr, Diaz A, Mehta M, Movsas B. Health related quality of life and cognitive status in patients with glioblastoma multiforme receiving escalating doses of conformal three dimensional radiation on RTOG 98-03. J Neurooncol. 2009 Nov;95(2):247-257. doi: 10.1007/s11060-009-9923-3. Epub 2009 Jun 16. PMID 19533025
- RESULTTsien C, Moughan J, Michalski JM, Gilbert MR, Purdy J, Simpson J, Kresel JJ, Curran WJ, Diaz A, Mehta MP; Radiation Therapy Oncology Group Trial 98-03. Phase I three-dimensional conformal radiation dose escalation study in newly diagnosed glioblastoma: Radiation Therapy Oncology Group Trial 98-03. Int J Radiat Oncol Biol Phys. 2009 Mar 1;73(3):699-708. doi: 10.1016/j.ijrobp.2008.05.034. Epub 2008 Aug 23. PMID 18723297
- RESULTWerner-Wasik M, Seiferheld W, Michalski J, et al.: Phase I/II conformal three-dimensional radiation therapy dose escalation study in patients with supratentorial glioblastoma multiforme: report of the Radiation Therapy Oncology Group 98-03 protocol. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-58, S163-4, 2004. Available online. Last accessed January 27, 2005.