Short Course Oncology Therapy - A study of adjuvant chemotherapy in colorectal cancer

Phase 1

Conditions: Colorectal Cancer
MedDRA version: 14.1Level: PTClassification code 10010033Term: Colorectal cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10010034Term: Colorectal cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2007-003957-10-GB

Lead Sponsor: Greater Glasgow Health Board (GGHB)/ University of Glasgow

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 6144

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).
•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)
•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)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
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.
•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: The study aims to ascertain whether 3 months of treatment for colorectal cancer is as efficacious as 6 months with the further aim of providing robust evidence on the cost effictiveness of reducing the duration of adjuvant therapy.;Secondary Objective: Economic analysis to assess the 2 treatment alternatives; comparison of 2 randomisation methodologies;Primary end point(s): Disease free survival (defined as time from randomisation to recurrence, development of new colorectal cancer or death from any cause)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall survival; Cost-effectiveness; Toxicity; Quality of Life

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