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 poor risk rectal cancer. - EXPERT-C

• Conditions: Poor risk operable rectal adenocarcinoma

• Registration Number: EUCTR2004-004707-38-SE
• Lead Sponsor: Prof David Cunningham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-15
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

b)Histological diagnosis of adeno- or undifferentiated non-small cell carcinoma of rectum.
c)Poor 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 into peri-rectal fat
iv) T4 tumours (including the involvement of bladder or vagina if surgical resection is possible with clear margins)
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

Exclusion Criteria

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.
e)Presence of metastatic disease or recurrent rectal tumour.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified