3D DOSE ESCALATION FOR PROSTATE CANCER

前列腺癌的 3D 剂量递增

• 批准号: 2101002
• 负责人: HOWARD M SANDLER
• 金额: $ 9.69万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 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 1997-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2101002
• 关键词: clinical trials; cooperative study; cytotoxicity; human subject; human therapy evaluation; male; neoplasm /cancer radiation therapy; prostate neoplasms; radiation therapy dosage; radiobiology; statistics /biometry

The overall objective of this proposal is to participate as a Radiotherapy Center in a multi-institutional series of Phase I, II, and Phase III clinical trials evaluating 3-D conformal radiotherapy and dose escalation for the treatment of advanced prostate cancer. Prostate cancer is the second most common cancer among men and, when present in its early stages, is often controlled well with either surgery or radiotherapy. In advanced cases, local recurrence is more frequent after radiotherapy and surgery is often not an alternative. As part of a multi-institutional group, a series of trials will be designed to test the hypothesis that an increased dose of radiotherapy can be delivered tolerably and with more effectiveness through the use of three-dimensional treatment planning. This project plans to enroll patients with large prostate cancers into a dose escalation trial to determine the maximum tolerated dose. The exact details of the protocol will be determined by the Executive Committee. Appended to this application is a detailed proposal for such a protocol. Briefly, Stage B-2, C (T2b, T2c, T3, T4) tumors would be entered and treated with gradually increasing doses of radiotherapy to determine the maximum tolerated dose. Data, including dose volume histogram analysis, will be supplied to an Operations Center for data on radiation-induced damage to normal tissues. Once the maximal tolerated dose has been reached, then a Phase III trial will be designed to test the efficacy of 3-D conformal radiotherapy. The University of Michigan is ideally suited to participate as a Radiotherapy Center in a national radiotherapy trial for 3-D dose escalation in prostate cancer due to: 1) its commitment to participate in multi-institutional protocols as evidenced by its involvement with SWOG; 2) its superior capability in 3-D treatment planning, treatment delivery and 3-D conformal prostate treatment; 3) its expertise in evaluation and QA of 3-D conformal treatment; 4) the availability of qualified and experienced support personnel; 5) the availability of patients to be entered in the trials; 6) the availability and experience of personnel to administer radiotherapy trials, and 7) its capability to exchange digital treatment planning data as demonstrated by previous involvement in a national treatment planning contract.

这项提议的总体目标是作为一个 一期、二期和三期多机构放射治疗中心 评估三维适形放射治疗和剂量的III期临床试验 晚期前列腺癌的治疗升级。前列腺 癌症是男性第二常见的癌症，当出现在 它的早期阶段，通常通过手术或 放射治疗。在晚期病例中，局部复发在以下时间更常见 放射治疗和手术通常不是一种选择。作为计划的一部分 多机构小组，将设计一系列试验来测试 认为可以提供更大剂量放射治疗的假设 通过使用可容忍和更有效的 立体治疗计划。本项目计划招生 巨大前列腺癌患者进入剂量递增试验 确定最大耐受量。协议的确切细节 将由执行委员会决定。附加在此之后 应用程序是对这种协议的详细建议。简而言之，舞台 B-2、C(T2b、T2c、T3、T4)肿瘤进入治疗 逐步增加放射治疗剂量以确定最大剂量 耐受剂量。数据，包括剂量体积直方图分析，将 提供给运营中心，以获取有关辐射损伤的数据 正常组织。一旦达到最大耐受量，则 第三阶段试验将设计用于测试3-D适形的疗效 放射治疗。密歇根大学非常适合 作为放射治疗中心参加全国放射治疗试验 前列腺癌的3-D剂量增加是因为：1)它致力于 参与多机构协议，ITS就是明证 参与SWOG；2)其在3-D治疗方面的卓越能力 计划、治疗实施和三维适形前列腺治疗；3)ITS 在三维适形治疗的评估和质量保证方面的专业知识；4) 是否有合格和有经验的支持人员；5) 参加试验的患者的可用性；6)可用性 和管理放射治疗试验的人员的经验，以及7)ITS 交换数字治疗计划数据的能力，如 曾参与国民治疗计划合同。