3-D DOSE ESCALATION STUDY FOR PROSTATE CANCER

前列腺癌的 3D 剂量递增研究

• 批准号: 3550106
• 负责人: SCOTT L SAILER
• 金额: $ 5.6万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 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/3550106
• 关键词: cancer information system; cooperative study; cytotoxicity; human subject; human therapy evaluation; longitudinal human study; male; medical complication; neoplasm /cancer radiation therapy; prostate neoplasms; radiation therapy dosage; radiobiology; statistics /biometry

The Department of Radiation Oncology at the University of North Carolina, in conjunction with radiation oncology facilities at Rex Hospital in Raleigh, NC and Cape Fear Valley Medical Center in Fayetteville, NC propose to work with a newly formed cooperative group to perform a dose escalation study in carcinoma of the prostate utilizing 3D treatment planning techniques. We will utilize a 3D treatment planning system that has been developed at UNC to perform the treatment planning on all patients at UNC although the treatments on patients coming from the affiliated institutions will have the radiation therapy delivered at the affiliate. We project that we will accrue patients from a patient base of approximately 200 new patients each year with localized prostate cancer treated with radiation therapy. Depending on the details of the protocol developed by the cooperative group, we expect to be able to enter approximately 75 patients per year on study. Our treatment planning system allows full 3D planning capabilities with beams eye views generated for field definition along with digitally reconstructed radiographs with structure overlay. Doses are calculated using full 3D information with tissue heterogeneity correction and with dose-volume histograms available. Specialized tools which have been developed at UNC using a common computer platform of the NCI Tools Contract Working Group will be made available to the cooperative group. We will participate fully in protocol development with a planned dose escalation scheme which would start at a dose of 7020 cGy with 2 dose escalations of 540 cGy each. Patients will be carefully monitored for toxicity with dose escalation performed when an appropriate number of patients (as determined by the statistical center) have been observed for a long enough time to assure that excessive toxicity will not occur. We will send full dose/volume information to the statistical and operations center using agreed upon magnetic tape data exchange formats. Lastly, if the results of the dose escalation study suggest a possible benefit of this approach, we will work to develop a Phase III study of high dose conformal radiation therapy compared to lower dose radiation therapy.

北卡罗来纳大学放射肿瘤学系， 与雷克斯医院的放射肿瘤设施联合 北卡罗来纳州罗利和北卡罗来纳州费耶特维尔的开普菲尔谷医疗中心 建议与新成立的合作小组合作进行剂量 利用 3D 治疗的前列腺癌升级研究 规划技术。 我们将利用 3D 治疗计划系统 已在北卡罗来纳大学开发，用于对所有患者执行治疗计划 北卡罗来纳大学的患者，尽管对来自北卡罗来纳大学的患者进行的治疗 附属机构将在 附属机构。 我们预计我们将从患者群体中吸引患者 每年约有 200 名新患者患有局限性前列腺 通过放射疗法治疗癌症。 取决于具体情况 由合作小组开发的协议，我们期望能够 每年约有 75 名患者参与研究。 我们的治疗 规划系统允许具有光束眼视图的完整 3D 规划功能 生成场定义以及数字重建 具有结构叠加的射线照片。 使用全 3D 计算剂量 具有组织异质性校正和剂量体积的信息 可用直方图。 北卡罗来纳大学开发的专用工具 使用 NCI 工具合同工作组的通用计算机平台 将提供给合作团体。 我们将参加 完全处于方案制定阶段，并制定了计划的剂量递增方案 将从 7020 cGy 的剂量开始，并逐步增加 2 次剂量 540 cGy 每个。 将仔细监测患者的剂量毒性 当有适当数量的患者（如 由统计中心确定）已被长期观察 足够的时间以确保不会发生过量的毒性。 我们将 将完整的剂量/体积信息发送给统计和操作部门 中心使用商定的磁带数据交换格式。 最后，如果 剂量递增研究的结果表明可能的益处 通过这种方法，我们将致力于开展高剂量的 III 期研究 适形放射治疗与低剂量放射治疗相比。