Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer (PROArCT)

Inclusion Criteria:

• Previously untreated and pathologically proven adenocarcinoma of the rectum.
• MRI staged T3 or T4, any N.
• Lower border of tumour must be within 12 cm of anal verge.
• Age greater than or equal to 18 years.
• ECOG Performance Status 0-1 (Appendix 2)
• Absolute neutrophil count greater than or equal to 1.5 x 109/L, haemoglobin greater than or equal to 90 g/L, and platelets greater than or equal to 100 x 109/L.
• Adequate renal function: GFR greater than or equal to 55 mL/min (derived from serum creatinine e.g. using the Cockcroft-Gault formula or measured by radioisotopic techniques).
• Bilirubin and ALT less than or equal to 1.5 x upper limit of normal.
• No symptomatic peripheral neuropathy greater than or equal to grade 2.
• Male or non-pregnant, non-lactating female. Patients on study with reproductive potential, or female partners with reproductive potential, must use an effective contraceptive.
• Has provided written informed consent for participation in this trial

Exclusion Criteria:

• Presence of metastatic disease.
• Prior pelvic radiotherapy
• Febrile intercurrent illness or infection.
• Previous history of unstable angina
• Cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment
• Acute coronary syndrome even if controlled with medication
• Myocardial infarction within the last 12 months
• Concurrent treatment with other anti-cancer therapy.
• Significant medical condition which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
• Locally recurrent rectal cancer.