Postoperative Radiation Therapy for Endometrial Carcinoma – a multicenter randomised phase III trial comparing external beam radiation and vaginal brachytherapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
Wortman BG, Creutzberg CL, Putter H, et al: Ten-year results of the PORTEC-2 trial for high-intermediate risk endometrial carcinoma: improving patient selection for adjuvant therapy. Br J Cancer. 2018 Oct;119(9):1067-1074. doi: 10.1038/s41416-018-0310-8. Epub 2018 Oct 25. Nout RA, Putter H, Jurgenliemk-Schulz IM, et al: Five-year quality of life of endometrial cancer patients treated in the randomised Post Operative Radiation Therapy in Endometrial Cancer (PORTEC-2) trial and comparison with norm data. Eur J Cancer.2012 Jul;48(11):1638-48. doi: 10.1016/j.ejca.2011.11.014. Epub 2011 Dec 14 Nout RA, Smit VTHB, Putter H, et al: Vaginal brachytherapy versus pelvic external beam radiotherapy for patients with endometrial carcinoma of high-intermediate risk (PORTEC-2): an open-label, non-inferiority, randomised trial. Lancet 375:816-823, 2010. Nout RA, Putter H, Jurgenliemk-Schulz IM, et al: Quality of life after pelvic radiotherapy or vaginal brachytherapy for endometrial cancer: first results of the randomized PORTEC-2 trial. J Clin Oncol 27:3547-3556, 2009.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Endometrial carcinoma, with one of the following combinations of postoperative FIGO stage and age:
- •a. Stage 1C grade 1 or 2 and age 60 or over;
排除标准
- •1. One of the following combinations of FIGO stage and age:
- •a. Stage 2B, 3 or 4;