Colon cancer MedDRA version: 20.0 Level: PT Classification code 10009944 Term: Colon cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Pegylated Interferon alfa 2a
Product Name: Pegylated Interferon alfa 2a
Pharmaceutical Form: Injection
INN or Proposed INN: peginterferon alfa-2a.
CAS Number: 215647-85-1
Other descriptiv
Sponsors
Ismail Gögenur
Ismail Gögenur
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 33
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to examine the effect of Interferon-a2a 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-a2a. ;Secondary Objective: Lymphocytic tumour infiltration Patient reported outcome measures Cytokine response NK-cell activity analysis ;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. ;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: The day prior to surgery and day 1,2,3,10 and 30 after surgery. | — |
Countries
Denmark
Contacts
Public ContactDepartment of Surgery
Department of Surgery Roskilde Hospital
Outcome results
None listed