EUCTR2009-010004-28-NL进行中（未招募）不适用
ACNS0331A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children with Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial.An Intergroup Study for Participation by COG and the Dutch Childhood Oncology Group – SKION (Stichting Kinderoncologie Nederland) - ACNS0331
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- COG
- 入组人数
- 455
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 < 1.5 x upper limit of normal (ULN) for age, and
- •- SGOT (AST) or SGPT (ALT) < 1.5 x upper limit of normal (ULN) for age.
- •3.2.5.3 Adequate Bone Marrow Function Defined as:
- •- Peripheral absolute neutrophil count (ANC) >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
排除标准
- •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.
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