A Phase II Study of Oxaliplatin Capecitabine and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer

Inclusion Criteria:

* Age over 18.
* Histological diagnosis of adenocarcinoma of rectum.
* Locally advanced/ poor prognosis primary rectal cancer defined by MRI criteria of any of the categories below;

  * Tumour within 2 mm of mesorectal fascia ie circumferential resection margin threatened
  * Any T3 tumour at/below levatores
  * T3c tumour at any other level ie tumour extends \>5 mm into peri-rectal fat
  * T4 tumour
  * Any T stage with 4 or more involved lymph nodes
* WHO performance status 0, 1 or 2.
* No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis or other investigations such as PET scan or biopsy if required.
* Adequate bone marrow function with platelets \> 100 X 109/l; WBC \> 3 X 109/l; neutrophils \> 1.5 X 109/l
* Normal renal function, with serum creatinine within the normal range or calculated creatinine clearance \>50 ml/min.
* Adequate hepatic function with serum total bilirubin \< 1.5 X upper limit of normal range.
* No concurrent uncontrolled medical conditions
* No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
* Adequate contraceptive precautions if relevant
* Informed written consent

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent
* Presence of metastatic disease or recurrent rectal tumour
* Renal impairment (creatinine clearance\<30 ml/min)
* Pregnancy or breast feeding
* Patients with a lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes
* Participation in any investigational drug study within the previous 4 weeks.
* Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months)
* Patients with any symptoms or history of peripheral neuropathy.
* Prior pelvic radiotherapy