| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10010033 |
| E.1.2 | Term | Colorectal cancer stage II |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10010034 |
| E.1.2 | Term | Colorectal cancer stage III |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 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. |
|
| E.2.2 | Secondary objectives of the trial |
| Economic analysis to assess the 2 treatment alternatives; comparison of 2 randomisation methodologies |
|
| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
tranSCOT - translational research
Funding has been secured to support the collection of FFPE blocks and bloods for patients on the SCOT trial. The aim of collecting this material (the transSCOT study) is to establish a large biobank of colorectal cancer tissue and blood with complete and comprehensive trial quality follow-up data which will act as the foundation for many future collaborative research projects and for combined projects with other funded tissue collections. Expected research projects arising will include definition of new prognostic markers in this group of patients, including defining whether there is a sub-group of patients for whom abbreviated therapy is not appropriate; and definition of pharmacogenetic markers of 5FU/capecitabine and oxaliplatin toxicity, particularly high grade diarrhoea and neurotoxicity.
Participation in the transSCOT study is not mandatory in order for a patient to take part in the main efficacy intervention in the SCOT trial Samples will only be collected/retrieved for those patients who consent specifically for this component of the study. Patients may consent to donate their FFPE block and / or to have their blood taken for submission to the Trials Office Translational Labs. It is important to note that the power of the translational study will be more greatly enhanced the larger the number of full set samples (FFPE / serum / EDTA) that we receive.
Tumour Specimens:
We plan to collect the paraffin embedded tumour tissue which will have been obtained at surgical resection of patient’s primary tumour prior to entry into SCOT.
Blood samples:
We will collect blood samples – a 5ml serum sample and a 10ml EDTA sample (for DNA) from each patient who consents to this.
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|
| E.3 | Principal 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.
|
|
| E.4 | Principal 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.
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|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Disease free survival (defined as time from randomisation to recurrence, development of new colorectal cancer or death from any cause) |
|
| E.5.2 | Secondary end point(s) |
| Overall survival; Cost-effectiveness; Toxicity; Quality of Life |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| duration of treatment regimens- short course vs long course (3 months vs 6 months) |
|
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 160 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| Recruitment to the trial will last approximately 5 years, patients will be followed up for survival purposes for a maximum of 7 years for completeness of overall survival. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 5 |
| E.8.9.1 | In the Member State concerned months | 7 |
| E.8.9.1 | In the Member State concerned days | |
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