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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT00276666
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven medulloblastoma
* The following variants of medulloblastoma are also eligible:
* Nodular/desmoplastic medulloblastoma
* Medullomyoblastoma
* Melanotic medulloblastoma
* Metastatic disease, meeting at least 1 of the following criteria:
* Unequivocal evidence on pre- or post-operative MR scan of supratentorial (stage M2) metastases and/or spinal metastases (stage M3)
* Tumor cells seen on cytospin analysis of lumbar cerebral spinal fluid (CSF) (stage M1) performed between 15 days and 21 days after surgery
* Involvement of CSF pathways by tumor is defined as the unequivocal identification of primitive neuroectodermal cells, either on cytological grounds or with a combination of cytological and immunocytological features (e.g., reactivity for GFAP or a neuronal marker, such as synaptophysin)
* Underwent surgery to remove the tumor no more than 6 weeks ago
PATIENT CHARACTERISTICS:
* Hemoglobin ≥ 10 g/dL
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Neurologically stable (or improving) during the week before starting radiotherapy
* Lansky (1-16 years) or Karnofsky (\>16 years) performance status 30-100%
* No active infection
* No prior malignant disease
* Not pregnant or nursing
* No syndrome with recognized potential for increased sensitivity to radiotherapy and/or chromosomal fragility
* Not require anesthesia
* No hearing loss or renal impairment that would make the patient unable to comply with 'Packer' chemotherapy protocol
PRIOR CONCURRENT THERAPY:
* No steroids, if possible, at the start of radiotherapy OR on a stable or reducing dose of steroids during the week before starting radiotherapy
* No prior chemotherapy or radiotherapy
* Dexamethasone should not be used as an anti-emetic unless other therapies fail
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT00276666
Study Brief:
Protocol Section:
NCT00276666