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:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-24 @ 6:39 PM
NCT ID:
NCT00437957
Eligibility Criteria:
Inclusion Criteria:
* Patients must have cytologically/histologically documented solid tumor malignancies
* Age \> 18 years old
* Patients must be candidates to receive WBR for unresectable brain metastases
* Patients must have ECOG performance status 0-2
* Patients must be able to give informed consent and able to follow guidelines given in the study
* Neurologic Function Status 0,1, or 2
* The patient has no major impairment of hematological function, as defined by the following laboratory parameters: WBC \>3.0x10\^9/L; ANC \> 1.5 x 10\^9/L; Hgb \>9.0g/dL; PLT \>100x10\^9/L. Red blood cell transfusions and repeat evaluations for study entry are allowed
* Patients must have adequate renal and normal hepatic function (creatinine \< 1.5 x upper limit of normal (ULN), bilirubin and SGOT (AST), SGPT (ALT) within 1.5 x the upper institutional normal limits) obtained within 4 weeks prior to registration.
* All patients of reproductive potential must use an effective method of contraception during the study and six months following termination of treatment. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to female patients who are older than 50 years and have not had a menstrual cycle in more than one year).
* Women of childbearing age must have a negative pregnancy test
* Patients must have 10 mm or greater brain lesion on MRI scan performed within 4 weeks of enrollment
Exclusion Criteria:
* Prior whole brain radiation
* More than 1 active malignancy which may potentially cause brain metastasis
* Patients on phenytoin, carbamazepine, phenobarbital, felbamate, meropenem, rifampin (Levetiracetam will be permitted)
* Patients with active or any history of seizure disorders
* Patients with uncontrolled nausea and vomiting
* Chemotherapy, radiotherapy, or hormonal therapy within 2 weeks prior to entering the study or have not recovered from prior treatment-related toxicities (grade 2 or less)
* Patients receiving any other investigational agents
* Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry.
* Leptomeningeal disease or hydrocephalous on MRI scan performed within 4 weeks of enrollment
* Pregnant and breast feeding women are excluded from the study because effects on the fetus are unknown and there may be a risk of increased fetal wastage.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00437957
Study Brief:
Protocol Section:
NCT00437957