NL-OMON52264招募中2 期
Organ preservation in patients with a good clinical response after neoadjuvant (chemo)radiation for rectal cancer: optimization of treatment strategies and defining the role of additional contact x-ray brachytherapy versus extending the waiting interval and local excision. - OPAXX study
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 168 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 168
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 64（—）
入选标准
- •histologically verified adenocarcinoma above the dentate line and within 10cm
- •of the anal verge;
- •neoadjuvant short-course radiotherapy for patients with 1) IRC and delayed
- •re-sponse evalation according to the Dutch national guidelines (cT1-3, cN1-2
- •lymph nodal status, no involved MRF or cT3c-d, N0-1 lymph nodal status without
- •pres-ence of significant distant metastases) without full dose chemotherapy in
- •the inter-val (e.g. Rapido-scheme) or 2) LARC due to comorbidity or frailty; OR
- •neoadjuvant long-course radiotherapy (chemoradiation) for patients with 1)
- •LARC according to the Dutch national guidelines (cT4 tumour, cN2 lymph nodal
- •status, lateral lymph node involvement, and/or involved MRF, without the
- •presence of significant distant metastases) or 2) early rectal cancer or IRC
- •and a strong wish for organ preservation;
- •clinically near-complete response or a small residual tumour mass <3 cm;
- •technically feasible to perform both treatment options (contact x-ray
- •brachythera-py or local excision);
- •age >18 years;
- •written informed consent.
排除标准
- •neoadjuvant or induction chemotherapy prior or adjacent to (chemo)radiation,
- •e.g. patients with a Rapido or M1-scheme are not eligible;
- •radiation dose >50.4 Gy or boost dose on the primary tumour;
- •presence of suspicious lymph nodes (yN1/N2) at first response evaluation;
- •residual tumour >= 3cm or over half of the circumference of the rectal lumen;
- •patients who are unable to undergo contact x-ray brachytherapy or local
- •patients who cannot tolerate a completion- or salvage-TME because of
- •comorbidi-ty or frailty;
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