Stage II colon cancer. MedDRA version: 9.1 Level: PT Classification code 10009954 Term: Colon cancer stage II
Conditions
Interventions
Trade Name: Avastin
Product Name: Bevacizumab
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Calcium Pharma Plc
Product Name: Calcium Leucovorin
Product Code: V03AF03
Pharmace
Sponsors
All Ireland Cooperative Oncology Research Group (ICORG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The distal extent of the tumour must be >/= 12cm from the anal verge. Patients must have a paraffin-embedded tumour specimen available for the evaluation of risk that is less than 50 days old. A histologically confirmed adenocarcinoma of the colon that meets Stage II carcimona criteria. >/= 8 lymph nodes must have been evaluated and reported. Patients with prior malignancies, including colorectal cancers, are eligible if they have been disease free for >/= 5 years and are deemed by their physician to be at low risk of recurrence. Patients with squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that have been effectively treated are eligible, even if these conditions were diagnosed within 5 years prior to randomisation. Patients must be >/= 18 years old. Patients must have ECOG performance status of 0-2. Patient must, within 2 weeks prior to randomisation, have: - postoperative absolute granulocyte count of >/=1500/mm3 (or /= 100,000/mm3 - postoperative evidence of adequate hepatic function - postoperative evidence of adequate renal function 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: A history of isolated, distant, non-contiguous intra-abdominal metastices, even if restricted. A presence of complete obstruction or perforation of the bowel. Systemic or radiation therapy initiated for this malignancy. Any significant bleeding that is not related to the primary colon tumour within 6 months prior to study entry. Gastroduodenal ulcer(s) determined to be active by endoscopy. Patients with a history od hypertension must have a measurement of 1.5 are not eligible, unless the patient is on full-dose anticoagulants. Patients with non-malignant systemoc disease (cardiovascular, renal, hepatic etc) that would preclude any of the study therapy drugs are elegible. Specifically excluded are patients with NYHA Class III or IV cardiac disease or current symptomatic arrhythmia. A hisotory of Transient Ischemic Attack (TIA) or cerebrovascular accident (CVA). A history of the following within the 12 months of study entry: - arterial thromboembolic events - unstable angina - Myocardial Infarction Symptomatic Peripherial Vascular Disease Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Disease Free survival at 3 years.;Main Objective: To demonstrate an improvement in 3-year disease-free survival for high-risk stage II colon cancer patients randomly assigned to 5-FU, leucovorin, oxaliplatin versus 5-FU, leucovorin, oxaliplatin and bevacizumab.;Secondary Objective: To compare overall survival between the regimes. To further define the toxicity profiles of the regimens. To prospectively determine the impact of tumour biological characteristics on the survival of patients with stage II colon cancer. | — |
Countries
Ireland
Outcome results
None listed