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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT01088035
Eligibility Criteria:
Inclusion Criteria:
* Patients must be enrolled before treatment begins.
* Patients must be ≥ 12 months and \< 22 years of age at the time of diagnosis.
* The target tumors are primary brain non-metastatic (M0) ependymomas tumors. Patients must have histologic verification of an ependymoma at diagnosis. Patients with the following world health organization (WHO) diagnoses will be eligible for this study:Ependymoma (Subtypes: cellular, papillary, clear cell and tanycytic) and Anaplastic Ependymoma
* Life expectancy of ≥ 8 weeks.
* Newly diagnosed ependymoma and must not have had any prior chemotherapy or radiotherapy.
* All patients must have:
* A pre-operative MRI scan of the brain with and without contrast. NOTE: CT scans are NOT sufficient for study eligibility since radiation therapy planning and responses will be based on MRI scans only.
* Post-operative head MRI scan with and without contrast (preferably within 72 hours post-operatively).
* Spinal MRI (T-1 weighted imaging with and without gadolinium) is required within 28 days of surgery if done post-operatively and within 14 days of surgery if done pre-operatively. For posterior fossa tumors, pre-operative MRI scans are preferred because surgically induced inflammation/blood can be difficult to distinguish from tumor.
* Lumbar CSF cytology examination obtained between 7 and 31 days following surgery.
* Adequate bone marrow function, defined as:
* Peripheral absolute neutrophil count (ANC) \>1500/μL
* Platelet count ≥ 100,000/μL (transfusion independent)
* Hemoglobin ≥ 10.0 gm/dl (may receive RBC transfusions)
* Adequate renal function defined as:
* Serum creatinine \< 1.5 times the upper limit of normal based on the patient's age, or creatinine clearance greater than 60 ml/min/1.73 m² corrected for age and body surface area.
* Adequate liver function defined as:
* Total bilirubin \<1.5 x the institutional normal
* SGOT (AST) or SGPT (ALT) \<2.5 x institutional normals.
* Patients must begin chemoradiotherapy within 56 days of definitive surgery.
* All patients and/or their parents or legal guardians must sign a written informed consent
* Patients must provide assent as per local IRB guidelines (if applicable).
* Patients and/or their families must consent to the mandatory biology studies, including serum Survivin levels, CSF Survivin levels, paraffin-embedded tissue and fresh-frozen tissue when available.
* Karnofsky/Lansky scoring greater than 50.
* Corticosteroid supportive care is permissible at the clinician's discretion prior to and during chemo-radiotherapy.
* Anti-seizure medication support is permitted as necessary and at the treating physician's discretion.
Exclusion:
* Prior chemotherapy or prior radiotherapy
* Patients who are pregnant or breast feeding, or patients (male or female) not employing adequate contraception. Acceptable means of birth control include IUD, oral contraceptive, subdermal implant, a condom with a contraceptive sponge or suppository or abstinence.
* Patients who are unable to undergo MR imaging
* Patients with evidence of metastatic disease on spine MRI or CSF sampling
* Patients with post-operative residual tumor \> 0.5 cm, unless a repeat surgery is performed making the residual tumor less than 1.5 cm². Note: Timing for enrollment and initiation of therapy will begin after second surgery if a repeat surgery is performed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
21 Years
Study:
NCT01088035
Study Brief:
Protocol Section:
NCT01088035