RTOG 91-15 CHEMOPREVENTION TRIAL TO PREVENT SECOND PRIMARY TUMORS

RTOG 91-15 预防第二原发肿瘤的化学预防试验

• 批准号: 6282772
• 负责人: KATHYRN GREVEN
• 金额: $ 3.63万
• 依托单位: WAKE FOREST UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6282772
• 关键词: 13 cis retinoate; cancer prevention; chemoprevention; clinical research; drug screening /evaluation; head /neck neoplasm; human subject; human therapy evaluation; neoplasm /cancer relapse /recurrence

The objective of this study is to test the efficacy of prolonged low-dose 13-cis Retinoic Acid in reducing risk of second primary tumors in patients who have had head and neck cancer controlled by surgery and/or radiation, and to evaluate the toxicity of low-dose oral 13-cRA administered daily for 3 years. A previous trial established significant activity of 13cRA in preventing second primary tu-mors in squamous cell CA of the head and neck, which occur at a rate of 3 to 4% per year in previously treated patients. GRAMT=M01RR071220077 The objective is to obtain preliminary evidence of the effectiveness of various doses of DMP 504 in the treatment of patients with elevated cholesterol levels. The safety and tolerability of all dosing levels will aslo be assessed. This is a multicenter, randomized, double-blind, placebo-controlled trial of two- panel design that included three DMP 504 dose levels. There will be 6 study sites and sufficient patients enrolled to provide 150 evaluable patients for statistical analysis.

本研究的目的是测试长期低剂量的疗效 13-顺式视黄酸降低患者第二原发肿瘤的风险 患有通过手术和/或放射控制的头颈癌的人， 并评估每天给予低剂量口服 13-cRA 的毒性 3年。 之前的一项试验证实了 13cRA 在 预防头颈部鳞状细胞CA中的第二原发肿瘤， 在既往接受过治疗的患者中，这种情况的发生率每年为 3% 至 4%。 格兰特=M01RR071220077 目的是获得有效性的初步证据 不同剂量的 DMP 504 治疗高血压患者 胆固醇水平。 所有剂量水平的安全性和耐受性将 也进行评估。 这是一项多中心、随机、双盲、 包含三个 DMP 504 的两组设计的安慰剂对照试验 剂量水平。 将有6个研究中心和足够的患者入组 提供150名可评估患者进行统计分析。