Combination Chemotherapy After Surgery in Treating Patients With High-Risk Stage II or Stage III Colorectal Cancer

• Conditions: Colorectal Cancer in Remission (Disease postoperativ); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-003957-10-DE
• Lead Sponsor: Greater Glasgow Health Board/University of Glasgow (GU)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-18
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9500

Inclusion Criteria

• Fully resected stage III colorectal cancer*
Or,
Fully resected high-risk stage II colorectal cancer* (defined as having one or more of
the following - T4 disease, tumour obstruction and/or perforation of the primary tumour
during the pre-operative period, inadequate nodal harvest as indicated by <10 nodes
examined, poorly differentiated histology, perineural invasion, peritoneal involvement
or extramural venous/lymphatic invasion).
See tumour staging guideline in Appendix 11 for clarification on SCOT
eligibility.
• No evidence of residual or metastatic disease.
• Ideally patients should be randomised within 11 weeks of surgery and treatment should
start within 2 weeks of randomisation. However as long as the surgery to cycle 1
treatment start date is = 13 weeks the patient will be considered eligible.
• WHO PS = 0 or 1.
• Age >18 years.
• Life expectancy >5 years with reference to non-cancer related diseases.
• Written informed consent.
• CEA = 1.2 X ULN (as per local values) (see Schedule of Assessments section 4.1
Baseline Evaluations for details).
• Patients with rectal cancer will be eligible unless they have had pre-operative combined
chemotherapy and radiotherapy, or are scheduled for post-operative combined
chemotherapy and radiotherapy.
• All rectal cancer patients included in the trial must have had TME type surgery with
negative (R0) resection margins (R0 defined as greater than 1mm clearance).

* All patients must have negative (R0) resection margins defined as greater than 1mm
clearance.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Previous chemotherapy*.
• Previous long course chemoradiotherapy (pre-operative short course radiotherapy is
allowed).
• Moderate/severe renal impairment (GFR/Creatinine Clearance <30 ml/min), as
calculated by the Cockcroft-Gault equation (Appendix 2).
• Absolute neutrophil count<1.5x109/L.
• Platelet count <100x109/L.
• Haemoglobin <9 g/dL.
• Aspartate aminotransferase/Alanine aminotransferase >2.5 x upper limit of normal (at least one of AST or ALT must be performed).
• Clinically significant cardiovascular disease. [i.e. active; or <12 months since e.g.
cerebrovascular accident, myocardial infarction, unstable angina, New York Heart
Association (NYHA – Appendix 4) grade II or greater congestive heart failure, serious
cardiac arrhythmia requiring medication, uncontrolled hypertension].
• Pregnancy/lactation or of child bearing potential and not using, or willing to use
medically approved contraception. (Postmenopausal women must have been
amenorrheic for at least 12 months to be considered of non-childbearing potential.)
• Previous malignancy other than adequately treated in situ carcinoma of the uterine
cervix or basal or squamous cell carcinoma of the skin, unless there has been a
disease-free interval of at least 5 years.
• Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency.

* No previous chemotherapy except chemotherapy administered with curative intent
completed more than 5 years ago and from which there are no residual complications.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - Assessment of the efficacy of 12 weeks of treatment versus 24 weeks of treatment and comparison of the associated toxicity<br>- Economic analysis to assess the cost effectiveness of the two treatment alternatives<br>- Comparison of two randomisation methodologies;Secondary Objective: Overall survival, cost-effectiveness, toxicity, and quality of life.;Primary end point(s): Disease-free survival (defined as time from randomisation to recurrence, development of new colorectal cancer or death from any cause).;Timepoint(s) of evaluation of this end point: Current surveillance due to the nature of the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall surveillance, cost-effectiveness, toxicity and quality of life;Timepoint(s) of evaluation of this end point: Current surveillance due to the nature of the study