3-D ESCALATION STUDY FOR PROSTATE CANCER

前列腺癌的 3-D 升级研究

• 批准号: 3550105
• 负责人: GERALD E HANKS
• 金额: $ 8.14万
• 依托单位: FOX CHASE CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-06-01 至 1997-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3550105
• 关键词: cooperative study; cytotoxicity; human morbidity; human subject; human therapy evaluation; longitudinal human study; male; neoplasm /cancer radiation therapy; prostate neoplasms; radiation therapy dosage; radiobiology

The overall objective of this study is to test the fundamental hypothesis of conformal radiation therapy applied to cancer of the prostate: tumor control in locally advanced cancer of the prostate can be increased by using conformal radiation therapy techniques that allow higher tumor doses while maintaining an acceptable level of normal tissue morbidity. To effect a study of sufficient statistical power requires a cooperative multi-institutional approach characterized by greater technical demands and coordination than is customary in clinical trials. To satisfy the more rigorous demands of a cooperative study in conformal radiation therapy, the following specific aims must be accomplished: 1. The development of a consensus definition of "conformal" for prostate treatment, To achieve a uniform definition of "dose to target volume", a consensus regarding the definition of the margin around the tumor must be achieved so that all participating institutions will respect the same definition of "conformal." This in turn requires a preliminary study statistically assessing tumor location, patient immobilization, set-up variations, patient motion, machine output uncertainties, variations in machine parameters, and the effect these variations have on the dose distribution. 2. The development of sensitive criteria for measuring normal tissue morbidity, It is imperative that the normal tissue morbidity not be increased by the higher doses that may be achievable with the conformal techniques. Consequently, sensitive measures of normal tissue response that provide statistically powerful detection of differences between conformal and conventional treatment will be developed. This tool will be tested during the above preliminary study on precision of treatment delivery and evaluated concurrently for patients under conventional treatment. Emphasis will be placed on identifying early indicators of late complications. 3. The evaluation of conformal radiation treatment. Using estimates of rates of tumor control and normal tissue morbidity available from the literature and the experience of participating institutions, a clinical dose escalation trial will be designed and performed in a multi-institutional setting that will test the fundamental hypothesis of conformal radiation therapy. 4. The optimization of conformal radiation treatment of the prostate, Using the dose response data gathered as part of these studies, computer algorithms will be implemented that minimize the expected morbidity of treatment, including themorbidity of failing to control the tumor. This algorithm will account both for the probability of a given injury as well as the morbidity of that injury. 5. The dissemination of results. So that the community at large can take advantage of the results of this study in treatment of the all patients, techniques and versions of conformal therapy will be developed that will Ix appropriate for institutions without highly specialized equipment who perform 80% of the treatment of the radiation treatment of prostate cancer in the United States.

本研究的总体目标是检验基本假设 适形放射治疗应用于前列腺癌：肿瘤 局部晚期前列腺癌的控制可以通过以下方式增加 使用适形放射治疗技术， 剂量，同时保持正常组织发病率的可接受水平。 为了实现具有足够统计功效的研究，需要合作 多机构方法，特点是技术要求更高 和协调性比临床试验中常见的要好。 满足 适形放射合作研究的更严格要求 治疗，必须实现以下具体目标： 1.前列腺“适形”一致定义的发展 为了实现“靶体积剂量”的统一定义， 关于肿瘤周围边缘的定义必须达成共识， 实现，以便所有参与机构将尊重同样的 定义为“共形”。“这反过来需要进行初步研究 统计学评估肿瘤位置、患者固定、设置 变化、患者运动、机器输出不确定性、 机器参数以及这些变化对剂量的影响 分布 2.测量正常组织的敏感标准的发展 发病率，这是必要的，正常组织发病率不被 通过使用适形的可实现的更高剂量而增加 技术.因此，正常组织反应的灵敏测量 其提供统计上强有力的检测， 将开发适形和常规治疗。 本工具将 在上述治疗精度初步研究期间进行测试 在常规条件下同时对患者进行分娩和评价 治疗 重点将放在确定以下方面的早期指标： 晚期并发症 3.适形放射治疗的评价。 使用的估计数 肿瘤控制率和正常组织发病率可从 文献和参与机构的经验，临床 剂量递增试验将在一个 多机构设置，将测试的基本假设， 适形放射治疗 4.前列腺适形放射治疗的优化， 使用作为这些研究的一部分收集的剂量反应数据，计算机 将实施算法，以最大限度地减少预期的发病率， 治疗，包括无法控制肿瘤的风险。 这 一个算法也会考虑到给定伤害的概率 与这种损伤的发病率一样高。 5.传播成果。这样整个社区就可以 本研究结果在所有患者治疗中的优势， 将开发适形治疗的技术和版本， IX适用于没有高度专业化设备的机构， 进行80%的前列腺放射治疗的治疗 癌症在美国