3D DOSE ESCALATION FOR PROSTATE CANCER

前列腺癌的 3D 剂量递增

• 批准号: 2100979
• 负责人: GERALD E HANKS
• 金额: $ 8.63万
• 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/2100979
• 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.

这项研究的总体目标是检验基本假设 适形放射治疗在前列腺癌中的应用：肿瘤 局部晚期前列腺癌的控制率可以通过以下方式提高 使用适形放射治疗技术，允许更高的肿瘤 剂量，同时保持可接受的正常组织发病率水平。 为了实现足够的统计能力的研究，需要一个合作的 以更大的技术需求为特征的多机构方法 和协调性比临床试验中惯常的。为了满足 对共形辐射合作研究的更严格要求 治疗方面，必须实现以下具体目标： 1.发展对前列腺癌“适形”的共识定义 治疗，以实现“剂量与目标体积之比”的统一定义，a 关于肿瘤周围边缘的定义必须达成共识 实现，以便所有参与机构都将尊重 “保形”的定义。这反过来需要进行初步研究。 统计评估肿瘤位置、患者固定、设置 变化，患者运动，机器输出不确定，变化 机器参数，以及这些变化对剂量的影响 分发。 2.制定测量正常组织的灵敏标准 发病率，最重要的是正常组织的发病率不能 增加了使用保形技术可能达到的更高剂量 技巧。因此，正常组织反应的敏感指标 在统计上提供了强大的差异检测功能 将发展适形和常规治疗。此工具将 在上述治疗精密度的初步研究中接受测试 在常规治疗下同时进行分娩和评估 治疗。重点将放在确定早期指标上 晚期并发症。 3.适形放射治疗的评价。使用估计的 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，一个临床 剂量递增试验将在一个 多机构环境将检验以下基本假设 适形放射治疗。 4.优化前列腺适形放射治疗， 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，将预期发病率降至最低 治疗，包括未能控制肿瘤的发病率。这 算法将同时考虑到给定受伤的概率 因为那次受伤的发病率。 5.成果传播。这样整个社区就可以 这项研究的结果在治疗所有患者中的优势， 将开发适形治疗的技术和版本，以 IX适用于没有高度专业化设备的机构 完成80%的前列腺癌放射治疗 癌症在美国。