Medulloblastoom standard risk MedDRA version: 12.0 Level: LLT Classification code 10027107 Term: Medulloblastoma MedDRA version: 12.0 Level: PT Classification code 10027107 Term: Medulloblastoma
Conditions
Interventions
Trade Name: Vincristine
Product Name: Vincristine
Pharmaceutical Form: Injection*
INN or Proposed INN: VINCRISTINE SULFATE
CAS Number: 2068782
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
COG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will begin treatment within 31 days of definitive surgery. Treatment will start no later than 14 days after having met eligibility criteria and being enrolled on study. Preoperative and postoperative cranial MRI with and without contrast must be available. 3.2.1 Age Patients must be greater than or equal to 3 years and less than 22 years at the time of diagnosis. 3.2.2 Diagnosis The presence of a posterior fossa medulloblastoma as determined by institutional pathologic evaluation. Presence of minimal volume, non-disseminated disease, as defined by the following criteria: 1) There must be unequivocal evidence that the maximal cross-sectional area of residual tumor is 1.5 cm2 or less on MRI, performed with contrast imaging (preferably within 48 hours, and at most within 21 days, of surgery) upon elimination of the tumor in all three phases. 2) No evidence of metastatic disease in the head, spine, or CSF. ?? Assessment must include a pre-operative (within 5 days prior to surgery) or postoperative enhanced MRI of the spine within 28 days after surgery ?? Cytological examination of CSF performed after surgery but before the time of enrollment. False positive cytology can occur within 10 days of surgery. Patients with positive CSF cytology obtained before 10 days after surgery may have cytology repeated to determine eligibility. Patients with brain stem involvement are eligible. 3.2.3 Performance Level (See Appendix I) Patients must have a performance level of = 50 using the Karnofsky for patients > 16 years of age and Lansky for patients = 16 years of age. 3.2.4 Prior Therapy Patients must have no previous radiotherapy or chemotherapy other than corticosteroids. 3.2.5 Organ Function Requirements: 3.2.5.1 Adequate renal function defined as: - Creatinine clearance or radioisotope GFR = 70ml/min/1.73m2 3.2.5.2 Adequate liver function defined as: - Total bilirubin 1500/µL - Platelet Count > 100,000/µL (transfusion independent) - Hemoglobin greater than 10 gm/dL, (may receive RBC transfusions) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 3.2.6.1 Pregnancy/Contraception The Chemoradiotherapy and Maintenance regimens are cytotoxic and potentially mutagenic. They may potentially affect an unborn or nursing child. Therefore, patients who are pregnant or breast-feeding will not be eligible. Patients of childbearing potential must practice an effective method of birth control while participating on the study. Females who have achieved menarche must have a negative pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether reducing the craniospinal dose of radiation therapy to 18.00 Gy in children 3-7 years of age does not compromise event-free survival and overall survival as compared to treatment with 23.40 Gy of craniospinal radiation; and to determine if reducing the irradiated volume of the primary site tumor boost from the whole posterior fossa to the tumor bed only will not compromise event-free and overall survival.;Secondary Objective: 1) To evaluate patterns of failure in children treated with an irradiation boost volume smaller than conventional posterior fossa volumes. 2) To reduce the cognitive, auditory and endocrinologic effects of treatment of average-risk medulloblastoma by reducing the dose of craniospinal irradiation therapy. 3) To determine if the audiologic and endocrinologic toxicity will be reduced with the use of limited tumor boost volume irradiation compared to patients treated with conventional target volumes of radiation. 4) To develop an optimal gene expression medulloblastoma outcome predictor, validated prospectively in a multi-institution randomized clinical trial. 5) To improve compliance with long-term quality of life and functional status data submission by educating institutional nurses to administer and submit for analysis a battery of four instruments. ;Primary end point(s): Primary endpoint Time to Event, where event is defined as time from study entry to disease progression, disease recurrence, death from any cause, or occurrence of a second malignant neoplasm. This is used to compute the eventfree survival (EFS) percent. | — |
Countries
Netherlands
Outcome results
None listed