E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009944 |
E.1.2 | Term | Colon cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 aim of this study is to examine the effect of Interferon-α2a given prior to surgery for colon cancer. The main objective is to examine the effect on post-operative immune suppression through comparison of immunological outcome parameters in patients treated with placebo versus Interferon-α2a. |
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E.2.2 | Secondary objectives of the trial |
Lymphocytic tumour infiltration Patient reported outcome measures Cytokine response NK-cell activity analysis
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients between the ages of 18 to 75 years 2. Patients diagnosed with colonic adenocarcinoma and scheduled for laparoscopic hemicolectomy. 3. ASA class I-III (Classification of the American Society of Anesthesiology) 4. 4: Must be able to understand and sign informed content and read Danish
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E.4 | Principal exclusion criteria |
• Patients with childbearing potential without a negative pregnancy test before initiating study drug and / or non-acceptance to the use of contraceptive methods * • ECOG score function> / = 3 • Serum creatinine more than 2 x ULN • Total serum bilirubin greater than 1.5 x ULN • Plasma ALAT higher than 3 x ULN • Previous depression diagnosed by a psychiatrist or in treatment with antidepressant • Autoimmune disease. • Uncontrolled thyroid disease. • Patients who are or have recently (within 6 months) received treatment with immunosuppressive agents other than corticosteroid treatment. • Epilepsy and / or other serious CNS disorders. • Patients that have undergone major surgery within one month before planned colon resection. • Known hypersensitivity to recombinant interferon or auxiliary products of Pegasys®. • Patients needing gas-anaesthesia (severe lung disease). * Spiral, pill, implant, transdermal patch, vaginal ring or depot injection. Sterile / infertile subjects are exempt from the use of contraception. To be considered sterile or infertile must generally be surgical sterilization (vasectomy, bilateral tubectomy, hysterectomy or ovariectomy) or be postmenopausal, defined as absent menstruation for at least 12 months prior to study enrolment.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome is a difference in genetic transcription of immunologically relevant genes obtained and anaæyzed through whole-blood genetic transcription profiling. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Whole-blood genomic profiling will be performed on the day before surgery and day 1,2,3,10 and 30 after surgery. |
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E.5.2 | Secondary end point(s) |
Lymphocytic tumour infiltration will be performed on the resected tumour and pre-operative sample taken during colonoscopy at the time of diagnosis in cases and controlles will be compared. Patient reported outcome measures, evaluation of possibole side-effects (through blood-samples and questionnaires), Cytokine response, NK-cell activity analysis and FLOW analysis for leucocytic subpopulations will all be performed on the same timepoints as whole-blood genomic profiling. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The day prior to surgery and day 1,2,3,10 and 30 after surgery. |
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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 | No |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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The end of the study is day 30 after surgery where the last blood samples are taken and last evaluation of possible side effects are performed. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |