Phase III trial comparing conventional adjuvant Temozolomide with dose-intensive Temozolomide in patients with newly diagnosed glioblastoma

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

1. Histopathologically proven diagnosis of glioblastoma. Since gliosarcoma is a variant of glioblastoma, gliosarcoma is an eligible diagnosis.
2. Patients must have at least 1 block of tissues available for analysis of MGMT status.
3. Diagnosis must be made by open surgical biopsy or excision.
4. The tumor must have supratentorial component.
5. Patients must have recovered from the effects of surgery, post-operative infection, and other complications before study registration.
6. A diagnostic cotnrast-enhanced MRI ( or CT-scan if MRI is not available) of the brain preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days prior to study registration.
7. Therapy must begin within 5 weeks after surgery.
8. Karnofsky performance status more or equal then 60.
9. Age >= 18 years.

Exclusion Criteria

1. Prior invasive malignacy unless disease free for more then 3 years.
2. Recurrent or multifocal malignant gliomas.
3. Histopathologically diagnosis made only by stereotactic biopsy.
4. Metastases detected below the tentorium or beyond the cranial vault.
5. Prior chemotherapy or radiosensitizers for cancers of the head and neck region.
65. Prior radiotherapy to the head or neck, resulting in overlap of radiation fields.
7. Severe, active co-morbidity:
* Unstrable angina and/or congestive heart failure requiring hospitalization.
* Transmural myocardial infarction within the last 6 months.
* COPD exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
* Hepatic insufficiency resulting in clinical jaundices and/or coagulation defects.
* Acquired Immune Deficiency Syndrome based upon current CDC definition; HIV testing is not required.
* Major illnesses or psychiatric impairments that in the investigator's opinion will prevent adminstiration or completion of protocol therapy.
* Active connectieve tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patients at high risk for radiaton toxicity.
8. Women of childbearing potrential and men who are secually active and not willing/able to use medically acceptabel forms of contraception.
9. Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug.
10. Prior allergic reaction to temozolomide.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine if dose-intensifying the adjuvant temozolomide component of the<br /><br>chemoradiation treatment enhances treatment efficacy as measured by overall<br /><br>survival.</p><br>

Secondary Outcome Measures

Name	Time	Method

Related Trials