EUCTR2004-004707-38-GB进行中（未招募）1 期
A multicentre randomised phase II clinical trial comparing oxaliplatin (Eloxatin), capecitabine (Xeloda) and pre-operative radiotherapy with or without cetuximab followed by total mesorectal excision for the treatment of patients with magnetic resonance imaging (MRI) defined high risk rectal cancer. - EXPERT-C
Royal Marsden NHS Trust0 个研究点目标入组 164 人开始时间: 2005年2月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •b) Histological diagnosis of adeno- or undifferentiated non-small cell carcinoma of rectum. c) High risk operable rectal cancer as defined by the presence on MRI of at least one of the following: i) Tumours within 1mm of mesorectal fascia i.e. circumferential resection margin threatened or involved ii) T3 tumours at/below levators iii) Tumours extending 5mm or more into peri-rectal fat iv) T4 tumours v) Presence of extra-mural venous invasion (primary tumour is therefore at least T3) d) WHO performance status 0-2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a) Any contraindications to MRI (eg. patients with pacemaker. c) Patients with rectal cancer which is deemed inoperable at diagnosis should not be entered into the study even if they are potentially operable if their primary is successfully downstaged by neoadjuvant treatment. This includes patients with locally advanced inoperable disease, such as tumour extending beyond the mesorectal fascia into pelvic side wall structures, or situations where surgical resection with clear margins is unlikely to be possible. d) T1-2 rectal cancer at any level. in the absence of other high risk factors (e.g. patients with T2 tumours withing 1 mm of mesorectal fascia may be entered in the study). e) Presence of metastatic disease or recurrent rectal tumour.
研究者
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