NCT00003417

Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme

Study Contact:

Study Phase:

PHASE1

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00003417

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

Phase I/II Radiation Dose Escalation Study Applying Conformal Radiation Therapy in Supratentorial Glioblastoma Multiforme

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Brain and Central Nervous System Tumors

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: carmustine
- Description:
- Arm Group Labels:
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels:

Sponsor

Radiation Therapy Oncology Group