Patients with high-risk, operable colon cancer MedDRA version: 14.1 Level: PT Classification code 10009955 Term: Colon cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10009956 Term: Colon cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Panitumumab
Product Code: AMG954
Pharmaceutical Form: Solution for infusion
Trade Name: Oxaliplatin
Pharmaceutical Form: Concentrate and diluent for solution for infusion
Trade Name: F
Sponsors
University Of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Histologically proven colon cancer with a radiological staging of greater than or equal to T3, NX, M0. 2. Patients who have been fully staged radiologically by CT scanning and are poor prognosis (ref to protocol for further info). 3. Fit for the neoadjuvant treatments; (details in protocol) 4. Patients who have presented with acute colonic obstruction may enter the trial only if a successful defunctioning or stent procedure has been performed. 5. Patients able and willing to provide written informed consent for the study. 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
Exclusion criteria: Exclusion criteria: 1. Patients with evidence of disseminated disease. 2. Patients with tumour with rectal cancer 3. Patients with peritonitis (secondary to perforated tumour) 4. Patients with obstruction, who are not defunctioned or stented. 5. Patients unable to give informed consent. 6. Patients with serious medical comorbidity 7. Patients with an indication for radiotherapy 8. Patients under the age of 18 or pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A high-quality, multi-centre randomised controlled trial to determine if giving the first 6 weeks of an optimum combination chemotherapy regimen prior to surgery, as opposed to 24 weeks post-surgery, can reduce the risk of recurrence in patients with high-risk operable colon cancer. The effect of the addition of the monoclonal antibody, EGFR, with demonstated results in later stage disease, will also be evaluated. The pilot phase of the study (150 patients recruited) will also investigate the accuracy of pre-treatment CT scan staging and assess the tolerability and feasibility of the treatments. The main objective of the trial is to establish: • Does neoadjuvant chemotherapy±panitumumab, an anti-EGFR monoclonal antibody, followed by deferred surgery and completion of chemotherapy post-operatively reduce 2-year recurrence as compared to surgery and postoperative chemotherapy±panitumumab? • Does adding panitumumab reduce 2-year recurrence? ;Secondary Objective: The secondary objectives of the trial are: • Is there down-staging of tumours following neoadjuvant therapy, in terms of: - reduced nodal involvement? - reduced margin involvement in the resected tumour, serosa or mesentery? - Improved quality of resection specimen (completeness of mesenteric envelope)? •What are the nature and frequency of adverse events associated with surgery following neoadjuvant therapy? •What impact does neoadjuvant therapy have on the quality of life of patients? •Are there health economic benefits for neoadjuvant chemotherapy? ;Primary end point(s): The primary outcome measure for the comparison of pre- plus post-operative versus post-operative chemotherapy alone will be freedom from recurrence (or persistent disease) two years following randomisation. This includes failure of macroscopic disease clearance at primary surgery as well as colon cancer recurrence. The rationale for choosing two-year recurrence as primary outcome is to maximise statistical power as almo | — |
Countries
Denmark, Spain, Sweden, United Kingdom
Outcome results
None listed