A Phase II Study of Oxaliplatin (Eloxatin) Capecitabine (Xeloda) and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer.
- 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
- 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
- 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
- Medical or psychiatric conditions that compromise the patient's ability to give
- 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