A Phase II Trial of Integrated Preoperative Radiotherapy and Chemotherapy With Oxaliplatin 5-FU and Folinic Acid in Patients With Locally Advanced Rectal Cancer
- 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
- 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
- Has provided written informed consent for participation in this trial
- 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.