Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT00792012
Eligibility Criteria:
Inclusion Criteria:
* Histopathologically confirmed WHO grade IV astrocytoma (GBM), tumor can be supra- or infra-tentorial in location but not located in the brain stem.
* Solitary or multifocal tumor.
* Tumor can be biopsied or resected, either totally or sub-totally.
* A pre-radiation therapy brain MRI is mandatory.
* Surgical cavity or surgical cavity + T1 enhancing residual tumor ≤ 6 cm in the largest diameter on the pre-radiation therapy MRI. In the case of multifocal tumor, the combined largest diameter of T1 enhancing tumor + surgical cavity ≤ 6 cm.
* Placement of bis-chloronitrosourea (BCNU) wafers at the time of surgery is allowed.
* Age \> 18 years at time of registration.
* Estimated survival of at least 3 months.
* Zubrod Performance Scale of 0-2 (Karnofsky performance scale ≥ 60).
* Hgb \> 9 gm; absolute neutrophil count (ANC) \> 1500/ul; platelets \> 100,000; Creatinine \< 1.5 times the upper limit of laboratory normal value; Bilirubin \< 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) \< 3 times the upper limit of laboratory normal value.
* Patients must sign study-specific informed consent form prior to registration.
* Men and women and members of all ethnic groups are eligible for this trial.
* Radiation therapy and chemotherapy must start within 8 weeks of tumor resection or biopsy
Exclusion Criteria:
* Patients with contraindications for MRI scanning.
* Prior temozolomide chemotherapy.
* Prior brain irradiation.
* Evidence of severe or uncontrolled psychiatric or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator.
* Acquired Immune Deficiency (HIV (+)/AIDS)
* Patients being treated on any other clinical protocols within 30 days prior to study entry or during participation in the study.
* Pregnant women or breast feeding women. Women of childbearing potential must practice medically approved contraceptive precautions. Men should be counseled and agreeable to follow acceptable birth control methods.
* Active connective tissue disorders, such as active lupus or scleroderma.
* Concurrent active malignancy at other sites.
* Frequent vomiting of medical condition which could interfere with oral medication intake (e.g. partial bowel obstruction).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00792012
Study Brief:
Protocol Section:
NCT00792012