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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT00085735
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed medulloblastoma located in the posterior fossa
* Standard-risk disease
* Minimal volume, non-disseminated disease, defined by the following:
* Residual tumor ≤ 1.5 cm\^2 confirmed by MRI with contrast imaging within 21 days after surgery
* No metastatic disease in the head, spine, or cerebrospinal fluid (CSF) confirmed by both of the following:
* Enhanced MRI of the spine within 5 days before surgery OR within 28 days after surgery
* Negative cytological examination of CSF after surgery, but before study enrollment
* Brain stem involvement allowed
* Performance status - Karnofsky 50-100% (\> 16 years of age)
* Performance status - Lansky 30-100% (≤ 16 years of age)
* Absolute neutrophil count \> 1,500/uL
* Platelet count \> 100,000/uL (transfusion independent)
* Hemoglobin \> 10 g/dL (transfusions allowed)
* Bilirubin \< 1.5 times upper limit of normal (ULN) for age
* AST or ALT \< 1.5 times ULN for age
* Creatinine clearance OR radioisotope glomerular filtration rate \>= 70 mL/min/1.73m\^2 or a serum creatinine based on age/gender as follows:
Age Maximum Serum Creatine (mg/dL)
* 1month to \< 6 months male: 0.4 female: 0.4
* 6 months to \<1 year male: 0.5 female: 0.5
* 1 year to \< 2 years male: 0.6 female: 0.6
* 2 to \< 6 years male: 0.8 female: 0.8
* 6 to \< 10 years male: 1 female: 1
* 10 to \< 13 years male: 1.2 female: 1.2
* 13 to \< 16 years male: 1.5 female: 1.4
* \>= 16 years male: 1.7 female: 1.4
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior chemotherapy
* Prior corticosteroids allowed
* No prior radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT00085735
Study Brief:
Protocol Section:
NCT00085735