Patients With Rectal Cancer: a "Wait-and-see" Approach

Prior treatment

• Previous radiotherapy to the pelvis (including brachytherapy)
• Unfit to receive any study treatment or subsequent surgical resection

Other illness

• Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months of randomisation)
• T1N0 disease without extra-mural venous invasion
• Unequivocal evidence of metastatic disease (includes resectable metastases)
• Major impairment of bowel function without defunctioning stoma/ileostomy (baseline grade 3 diarrhoea or clinically significant faecal incontinence)
• History of another malignancy within the last 5 years except successfully treated basal cell cancer of skin or carcinoma in situ of uterine cervix.
• Known Gilberts disease (hyperbilirubinaemia)
• Gastrointestinal disorder which would interfere with oral therapy and its bioavailability

Other

• Enlarged extramesorectal nodes
• Known dihydropyrimidine dehydrogenase deficiency
• Taking warfarin or phenytoin or sorivudine
• Pregnant, lactating, or pre-menopausal women not using adequate contraception

• Pelvic MRI defined disease (at least one of the following):
  • mesorectum involved or breached - includes involvement of adjacent organ (s) (T3-T4)
  • involvement of muscularis propria (T2)
  • extra-mural vascular invasion
  • tumour deposit within the mesorectum
  • one or more involved mesorectal lymph node
• Patients are considered medically fit for oncologic resection
• ECOG performance status 0 or 1
• No evidence of established metastatic disease (CT chest and abdomen)
• Absolute neutrophil count \>1.5x109/L; platelets \>100x109/L,
• Serum transaminase \<3 x ULN;
• Adequate renal function (Cockroft Gault estimation \>50 mL/min)
• Bilirubin \<1.5 x ULN
• Ability to comply with oral medication
• Willingness and ability to give informed consent and comply with treatment and follow up schedule
• Age 18 or over