SCOT

STUDY STATUS

Open to recruitment.
Target recruitment: 9500 patients
Current recruitment: 83 patients (December 2008)
Number of active sites: 55

 

STUDY SCHEMA

INCLUSION CRITERIA

• Fully resected stage III colorectal cancer or high-risk stage II disease (defined as T4 disease, tumour perforation, obstruction, <10 nodes examined, poorly differentiated histology or extramural venous/lymphatic invasion).
• Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy and radiotherapy. Rectal patients must have had TME type surgery with negative (R0) resection margins.
• No evidence of residual or metastatic disease. 
• Within 10 weeks of surgery at the time of randomisation (not applicable to patients being treated after completing 12 weeks of treatment).
• WHO PS = 0 or 1.
• Age >= 18 years of age.
• Life expectancy > 5 years with reference to non-cancer related morbidity.
• CEA within normal limits.
• Written informed consent.

EXCLUSION CRITERIA

• Previous chemotherapy.
• Previous abdomino-pelvic radiotherapy.
• Moderate/severe renal impairment (GFR < 30 ml/min).
• Absolute neutrophil count < 1.5 x 10^9 /L.
• Platelet count < 100 x 10^9 /L.
• Haemoglobin < 9 g/dl.
• Liver function tests > 2.5 x ULN.
• Clinically significant cardiovascular disease.
• Previous malignancy.
• Known DPD deficiency.
• Pregnancy/lactation or of child bearing potential & not using adequate contraception.

STUDY OBJECTIVES

Primary:

• 3 year disease free survival

Secondary:

• Overall Survival
• Cost-effectiveness
• Toxicity
• Quality of Life

KEY DATES

Oncology Clinical Trials Office (OCTO)