NL-OMON47895已完成3 期
Randomized Multicentre Phase III study of short course radiation therapy followed by prolonged pre-operative chemotherapy and surgery in primary high risk rectal cancer compared to standard chemoradiotherapy and surgery and optional adjuvant chemotherapy (RAPIDO study) - RAPIDO
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 361
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Biopsy-proven, newly diagnosed primary rectal adenocarcinoma.
- •Locally advanced tumour fulfilling at least one of the following criteria on
- •pelvic MRI indicating high risk of failing locally and/or systemically:
- •o Clinical stage (c) T4a
- •o Positive MRF, i.e. tumour <= 1 mm from the mesorectal fascia
- •Staging done within 5 weeks before randomization.
- •Age >= 18 years.
- •ECOG Performance Status of 0 - 1.
排除标准
- •Extensive growth into cranial part of the sacrum (above S3) or the
- •lumbosacral nerve roots.
- •Metastatic disease or recurrent rectal tumour. Familial Adenomatosis
- •Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC),
- •active Crohn*s disease or active ulcerative Colitis.
- •Pregnancy or lactation.
研究者
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