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当前卵巢癌的临床学术试验:妇科癌症协作组和美国国家癌症研究所临床试验计划会议,2009 年 5 月。

Current academic clinical trials in ovarian cancer: Gynecologic Cancer Intergroup and US National Cancer Institute Clinical Trials Planning Meeting, May 2009.

机构信息

National Cancer Institute, National Institutes of Health, Bethesda, MD 20892-7436, USA.

出版信息

Int J Gynecol Cancer. 2010 Oct;20(7):1290-8. doi: 10.1111/IGC.0b013e3181ee1c01.

Abstract

OBJECTIVE

To review the current status of large phase academic clinical trials for women with ovarian cancer, address cross-cutting issues, and identify promising areas for future collaboration.

METHODS

In May 2009, the Gynecologic Cancer Intergroup, which represents 19 Cooperative Groups conducting trials for women with gynecologic cancer, and the US National Cancer Institute convened a Clinical Trials Planning Meeting.

RESULTS

The topics covered included the impact of new developments in cancer biology upon molecular targets and novel agents, pharmacogenomics, advances in imaging, the potential benefit of diet and exercise to reduce the risk of recurrence, academic partnership with industry, statistical considerations for phases 2 and 3 trials, trial end points, and symptom benefit and health-related quality-of-life issues. The clinical trials discussed spanned the spectrum of ovarian cancer from initial diagnosis, staging, and cytoreductive surgery to consolidation chemotherapy, and treatment of recurrent disease.

CONCLUSIONS

Ongoing and effective collaboration with industry, government, and patients aims to ensure that the most important scientific questions can be answered rapidly. We encourage women with ovarian cancer and their oncologists to consider participation in the academic clinical trials conducted by the member groups of the Gynecologic Cancer Intergroup.

摘要

目的

回顾当前卵巢癌女性大型学术临床试验的现状,解决跨领域问题,并确定未来合作的有前景领域。

方法

2009 年 5 月,代表为妇科癌症患者开展试验的 19 个合作组的妇科癌症协作组和美国国家癌症研究所召开了临床试验规划会议。

结果

涵盖的主题包括癌症生物学新发展对分子靶标和新型药物的影响、药物基因组学、影像学进展、饮食和运动降低复发风险的潜在益处、与工业界的学术合作、2 期和 3 期试验的统计考虑因素、试验终点以及症状获益和健康相关生活质量问题。讨论的临床试验涵盖了卵巢癌从初始诊断、分期和细胞减灭术到巩固化疗以及复发性疾病治疗的整个范围。

结论

与工业界、政府和患者的持续有效合作旨在确保能够快速回答最重要的科学问题。我们鼓励卵巢癌患者及其肿瘤学家考虑参加妇科癌症协作组成员组开展的学术临床试验。

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