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: 6309908
• 负责人: KATHYRN GREVEN
• 金额: $ 3.88万
• 依托单位: WAKE FOREST UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2001-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6309908
• 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

This is a clinical research study to evaluate the effectiveness of low-dose 13-cis retinoic acid in preventing second primary tumors in patients who have been successfully treated for cancer of the head and neck. Head and neck cancer accounts for 5% of all cancers in the USA.Standard treatment for stage III and IV disease is surgery and/or radiotherapy (RT) with the major causes of failure being loco-regional and distant metastases. Standard treatment for stage I and II disease is either surgical excision or RT with the major causes of failure being development of second primary tumors. In 1983, a chemopreventive study of high-dose 13-cis retinoic acid (13-cRA) versus placebo in patients with head and neck squamous cell carcinoma revealed that the 13-cRA treatment significantly reduced the incidence of second primary tumor development. Toxicity in the 13-cRA group was more severe and more often intolerable than in the placebo group. This study will determine whether low-dose 13-cRA is an effective long-term treatment for reducing second primary tumors. The side effects from this medication will also be evaluated.

这是一项临床研究，旨在评估低剂量 13-顺式视黄酸在预防已成功治疗头颈癌患者的第二原发肿瘤方面的有效性。 在美国，头颈癌占所有癌症的 5%。III 期和 IV 期疾病的标准治疗是手术和/或放疗 (RT)，失败的主要原因是局部和远处转移。 I 期和 II 期疾病的标准治疗是手术切除或放疗，失败的主要原因是第二原发肿瘤的发展。 1983年，一项针对头颈鳞状细胞癌患者的高剂量13-顺式视黄酸（13-cRA）与安慰剂的化学预防研究表明，13-cRA治疗显着降低了第二原发肿瘤的发生率。 13-cRA 组的毒性比安慰剂组更严重且更难以耐受。这项研究将确定低剂量 13-cRA 是否是减少第二原发肿瘤的有效长期治疗方法。 还将评估这种药物的副作用。