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 magentic resonance imaging defined high risk rectal cancer

Completed

• Conditions: Cancer; Rectal cancer

• Registration Number: ISRCTN99828560
• Lead Sponsor: Royal Marsden NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

1. Aged 18 years or over
2. Histological diagnosis of adeno- or undifferentiated non-small cell carcinoma of rectum
3. High risk operable rectal cancer as defined by the presence on MRI of at least one of the following:
a. tumours within 1 mm of mesorectal fascia i.e. circumferential resection margin threatened or involved
b. T3 tumours at/below levators
c. tumours extending into more than or equal to 5 mm into peri-rectal fat
d. T4 tumours (including the involvement of bladder or vagina if surgical resection is possible with clear margins)
e. presence of extra-mural venous invasion (primary tumour is therefore at least T3)
4. World Health Organisation (WHO) performance status of zero to two
5. No evidence of metastatic disease as determined by Computerised Tomography (CT) scan of chest and abdomen or other investigations such as Positron Emission Tomography (PET) scan or biopsy if required
6. Adequate bone marrow function with platelets more than 100 x 10^9/l, White Blood Cells (WBC) more than 3 x 10^9/l and neutrophils more than 1.5 x 10^9/l
7. Serum bilirubin less than 1.5 x Upper Limit of institutional Normal range (ULN) and transaminases less than 2.5 x ULN
8. Serum creatinine less than ULN or calculated creatinine clearance more than 50 ml/min
9. No concurrent uncontrolled medical condition
10. No active malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last ten years
11. Life expectancy of more than three months
12. Adequate contraceptive precautions if relevant
13. Informed written consent

Exclusion Criteria

1. Any contraindications to MRI (e.g. patients with pacemakers)
2. Medical or psychiatric conditions that compromise the patient?s ability to give informed consent
3. 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
4. T1-2 rectal cancer at any level
5. Presence of metastatic disease or recurrent rectal tumour
6. Concurrent uncontrolled medical conditions
7. Any previous chemotherapy or radiotherapy, and any investigational treatment for rectal cancer
8. Pregnancy or breast feeding
9. Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract
10. Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication) or myocardial infarction within the last 12 months
11. Patients with any symptoms or history of peripheral neuropathy

Study & Design

• Study Type: Interventional
• Study Design: Not specified