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

EORTC0 sites834 target enrollmentAugust 23, 2006

Overview

No summary available.

Registry

who.int

Start Date

August 23, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Histopathologically proven diagnosis of glioblastoma multiforme.
•Patients must have at least 1 block of tissue available for analysis of MGMT status; fresh frozen tumor tissue acquisition is encouraged.
•Diagnosis must be made by surgical biopsy or excision.
•The tumor must have supratentorial component.
•Patients must have recovered from the effects of surgery, post\-operative infection, and other complications before study registration.
•A diagnostic contrast\-enhanced MRI or CT scan (if MRI is not available) of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days prior to study registration. Preoperative and postoperative scans must be the same type. If CT scans were performed perioperatively, a CT and an MRI should be performed before randomization.
•Patients diagnosed only by stereotactic biopsy do not require the postoperative scan. However, these patients will only be eligible once review of the tissue block determines that an adequate sample is available for molecular analysis.
•Patients unable to undergo MR imaging because of non\-compatible devices can be enrolled, provided pre\- and post\-operative contrast\-enhanced CT scans are obtained and are of sufficient quality.
•Therapy must begin \= 5 weeks after surgery.
•History/physical examination within 14 days prior to study registration.

•Prior invasive malignancy (except for non\-melanomatous skin cancer) unless disease free for \= 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible).
•Recurrent or multifocal malignant gliomas
•Metastases detected below the tentorium or beyond the cranial vault.
•Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable.
•Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
•Severe, active co\-morbidity, defined as follows:
•Unstable angina and/or congestive heart failure requiring hospitalization
•Transmural myocardial infarction within the last 6 months
•Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
•Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration