CLINICAL INVESTIGATIONS OF HODGKIN'S DISEASE

霍奇金病的临床研究

基本信息

批准号：
3200541
负责人：
SAUL A ROSENBERG
金额：
$ 17.03万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
1992
资助国家：
美国
起止时间：
1992-02-07 至 1997-01-31
项目状态：
已结题

项目摘要

The clinical investigations of Hodgkin's disease (HD) in adults and children described in this application include four clinical trials which are largely based upon the cumulative knowledge of therapeutic efficacy and early and late effects of treatment of approximately 2200 patients with HD at Stanford University over a 30 year time span. In addition, plans to continue the followup of patients participating in previous clinical trials, documentation of the complications of therapy and maintenance of a large database are described. The overall objectives of the adult and pediatric clinical protocols have a striking symmetry: refinement of treatment as a function of stage and tumor burden, and further minimization of early morbidity and/or late complications of therapy. There are four clinical protocols: one each for favorable, limited stage HD in adults and children and one each for unfavorable (bulky or advanced stage) HD in adults and children. Each of the protocols tests a novel chemotherapy combination which uses drugs and cumulative doses selected to avoid pulmonary and cardiac dysfunction, sterility and leukemogenesis. In adults, the increased dose intensity of the chemotherapy for unfavorable disease is anticipated to increase the efficacy while allowing abbreviation of the duration of therapy. In children, the novel chemotherapy is anticipated to result in similar, excellent cure rates, but will increase survival in the reduction of fatal late effects. Radiation therapy is used more sparingly than in previous trials in order to reduce late effects, which include second malignancy in adults and soft tissue and bone growth in children. Specifically, children receive low dose irradiation to involved fields. Adults with favorable, limited disease receive reduced volume irradiation made possible through the use of a minimally toxic chemotherapy (in a randomized trial compared to standard extended field irradiation), while adults with extensive disease receive irradiation only to initial bulky or residual disease. All patients participating in these studies will be clinically staged such that the attendant risks and morbidities of laparotomy and splenectomy will be avoided. An important part of this application is the continued followup of patients enrolled on prospective clinical trials at Stanford University since 1962 for endpoints of survival, from relapse and documentation of the long term effects of therapy. This includes the description of the long-term morbidity, fatal treatment communications, causes of death and survival in over 2200 patients with HD treated at Stanford University. Prospective evaluations of cardiac and pulmonary function, growth and fertility which began in 1980 will continue. These data are maintained in a sophisticated databank, representing a national resource for the efficacy and complications of treatment of HD.

成人霍奇金氏病（HD）的临床研究和本应用程序中描述的儿童包括四个临床试验主要基于治疗功效的累积知识和大约2200例HD患者治疗的早期和晚期影响在斯坦福大学（Stanford University）超过30年的时间。此外，计划继续对参加以前临床的患者进行随访试验，治疗并发症的记录和维护描述了大数据库。成人的总体目标小儿临床方案具有惊人的对称性：改进治疗与阶段和肿瘤负担的关系，并进一步最小化早期发病率和/或治疗后期并发症。有四个临床方案：每个人都有一个成人有限的，有限的阶段HD和儿童，每个儿童都不利于（笨重或高级舞台）高清成人和儿童。每个方案都测试了一种新型化学疗法使用药物和累积剂量的组合来避免肺和心脏功能障碍，无菌性和白血病发生。在成年人，化学疗法的剂量强度增加了不利预计疾病会增加疗效，同时缩写治疗持续时间。在儿童中，新颖的化疗是预计会产生类似的优质治疗率，但会增加在减少致命后期作用的生存。使用放射治疗比以前的试验更加谨慎，以减少迟到效应，其中包括成人的第二个恶性肿瘤，软组织和骨骼生长在儿童中。具体而言，儿童接受低剂量照射到涉及的字段。有利，有限疾病的成年人降低通过使用最小毒性使体积辐照成为可能化学疗法（在随机试验中与标准扩展场相比辐照），而患有广泛疾病的成年人仅接受辐射最初的笨重或残留疾病。所有参加这些的患者研究将在临床上上演，以使随之而来的风险和剖腹手术和脾切除术的病态性将避免。一个重要的本申请的一部分是对入学的患者的持续随访自1962年以来，斯坦福大学的前瞻性临床试验终点生存，复发和文献的长期影响治疗。这包括对长期发病率，致命的描述治疗通讯，死亡原因和生存率超过2200 在斯坦福大学接受高清治疗的患者。前瞻性评估从1980年开始的心脏和肺功能，生长和生育将继续。这些数据保存在复杂的数据库中，代表国家资源的功效和复杂性高清处理。