CLINICAL HYPERTHERMIA--HYPERTHERMIA & RADIATION THERAPY FOR PROSTATE CANCER

临床热疗--HYPERTHERMIA

• 批准号: 6102103
• 负责人: BRUCE A BORNSTEIN
• 金额: $ 34.11万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-07-28 至 2001-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6102103
• 关键词: adenocarcinoma; antineoplastics; biopsy; bladder neoplasm; clinical research; clinical trial phase I; combination cancer therapy; computed axial tomography; computer simulation; human morbidity; human subject; human therapy evaluation; hyperthermia therapy; neoplasm /cancer radiation therapy; neoplasm /cancer thermotherapy; prostate neoplasms; prostate specific antigen; quality of life; radiation sensitivity; radiosensitizer; stress proteins; triazines; ultrasound; ultrasound therapy

The major focus of this program is on disease site-specific therapy. Locally advanced prostate cancer and bladder cancer are deep-seated tumor sites with high rates of local failure. In order to improve the local tumor control in these sites we will take advantage of the syergistic effect between hyperthermia (HT) and radiation. Using a site-specific approach to heat the prostate and the bladder we will test the hypothesis that the combination of heat and irradiation leads to improved local tumor control which may lead to increased patient survival. We plan to correlate clinical outcome with the tumor and normal tissue temperatures achieved and with biological parameters measured in biopsy sampler of patient's tumors. The three specific areas of clinical research are as follows; PROSTATE CANCER: We are combining a site-specific HT treatment method with radiation therapy (RT) to treat patients with locally advanced adenocarcinoma of the prostate. HT will be delivered twice during standard RT using a previously developed transrectal ultrasound applicator that has been shown capable of heating the prostate gland. The primary endpoints for this Phase II study are toxicity and efficacy (as measured by tumor response). Survival and quality of life will also be evaluated. DEEP TUMORS: We will continue to evaluate athe capabilities and limitations of athe focused segmented ultrasound machine (FSUM) hyperthermia system combined with radiation therapy to treat advanced and deep seated tumors using the clinical protocol in progress. We also plan to evaluate athe potential role of RT delivered by the FSUM when combined with external beam RT to treat patients with medically inoperable or advanced transitional cell carcinoma of the bladder. HT will be delivered twice during the course of RT; warn irrigation of the bladder is available to improve the homogeneity of HT. Improved local tumor control in these patients may lead to more frequent urinary bladder organ preservation. HYPERTHERMIA MODIFIERS: We will determine the efficacy and toxicity of combined HT, RT, and chemical modifiers in a series of Phase II clinical trials designed to treat locally persistent, recurrent, or metastic superficial tumors. The first modifier to be tested will be etanidazole; the second study will evaluate tirapazimine.

该计划的主要重点是疾病部位特异性治疗。 局部晚期前列腺癌和膀胱癌是深部肿瘤 局部故障率高的站点。 为了改善当地 在这些部位的肿瘤控制中，我们将利用 热疗（HT）和辐射之间的关系。 使用位点特异 加热前列腺和膀胱的方法，我们将测试假设 加热和辐射的结合可以改善局部肿瘤 这可能会增加患者的生存率。 我们计划将 达到肿瘤和正常组织温度的临床结局， 在患者肿瘤的活检取样器中测量生物学参数。 临床研究的三个具体领域如下： 前列腺癌：我们正在结合特定部位的HT治疗方法， 放射治疗（RT）治疗局部晚期 前列腺腺癌。 HT将在标准期间交付两次 RT使用先前开发的经直肠超声施源器， 能够加热前列腺 主要终点 这项II期研究的目的是毒性和疗效（根据肿瘤大小测量）。 响应）。 还将评估生存率和生活质量。 深度肿瘤：我们将继续评估可移植性， 双聚焦分段超声机（FSUM）的局限性 热疗系统结合放射治疗晚期和晚期 正在进行中的临床治疗。 我们还计划 评价FSUM联合使用时提供RT的潜在作用 使用外部射束RT治疗医学上无法手术或 晚期膀胱移行细胞癌。 HT将交付 在RT过程中两次;膀胱的警告冲洗可用 以改善HT的均匀性。 改善这些患者的局部肿瘤控制 患者可能会导致更频繁的膀胱器官保存。 体温调节剂：我们将确定 在一系列II期临床试验中， 设计用于治疗局部持续性、复发性或转移性 浅表肿瘤 第一个要测试的改性剂将是依他硝唑; 第二项研究将评估替拉帕齐明。