PHASE III K XRT FOLLOWED BY ONE OF TWO ADJUVANT CHEMOTHERAPY REGIMENS

III 期 K XRT，随后采用两种辅助化疗方案之一

• 批准号: 6265744
• 负责人: DIANE M PUCCETTI
• 金额: $ 3.35万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265744
• 关键词: child (0-11); cis platinum compound; clinical research; cognition; combination chemotherapy; cyclophosphamide; drug screening /evaluation; human subject; human therapy evaluation; lomustine; medulloblastoma; neoplasm /cancer chemotherapy; neoplasm /cancer radiation therapy; vincristine

This is a multi-group research study which plans to evaluate the overall progression-free survival of children with average-risk medulloblastoma treated with craniospinal radiation and local boost radiotherapy plus one of two adjuvant chemotherapy regimens differing in the replacement of CCNU by cyclophosphamide. The long-term neurocognitive, endocrinologic and cardiopulmonary sequelae of radiotherapy with adjuvant chemotherapy will be determined, as well as the feasibility of routine surveillance scans to detect sub-clinical recurrent disease. Another objective of this study will be to evaluate the sensitivity of molecular and biochemical techniques to predict progression-free survival and disease relapse. Following surgery, patients will be randomized to receive Regimen A or B of treatment. Both regimens will include 2340 cGy of craniospinal radiation and 3240 cGy of boost radiation directly to the primary tumor with weekly vincristine doses. Six weeks following the completion of radiotherapy, patients will begin eight cycles of maintenance chemotherapy for Regimen A; CCNU, cisplatin, and vincristine or Regimen B; cyclophosphamide, vincristine and cisplatin.

这是一项多组研究，该研究计划评估用颅骨脊髓放射线和局部BOOST放射治疗治疗的平均危险固定细胞瘤儿童的总体无进展生存期，以及两种辅助化疗方案之一，在CCNU替换CCNU中被环磷酰胺替代。 将确定辅助化疗的放射疗法的长期神经认知，内分泌和心肺后遗症，以及常规监测扫描以检测下临界复发性疾病的可行性。 这项研究的另一个目的是评估分子和生化技术的敏感性，以预测无进展的生存和疾病复发。手术后，将随机分配患者接受治疗方案A或B治疗。 两种方案都将包括2340 CGY的颅脊髓辐射和3240 CGY的升压辐射直接以每周的长春新碱剂量直接向原发性肿瘤。 放疗后六个星期，患者将开始进行八个疗程A的维持化学疗法。 CCNU，顺铂和长春新碱或疗法B；环磷酰胺，长春新碱和顺铂。