None listed
Conditions
Brief summary
This is a phase III clinical trial comparing the combination of capecitabine and oxaliplatin (XELOX) versus the combination of 5-FU/LV and oxaliplatin (FOLFOX) as an adjuvant therapy in patients with operated colorectal cancer of stages B2 (high risk) and C. The primary endpoint is to compare the 3-year DFS (disease free survival) between the two group therapies
Interventions
(XELOX) Xeloda: 1000 mg/m2 twice daily [by mouth (p.o.), morning and evening within 30 min of last meal], days 1 to 14 Oxaliplatin: 130 mg/m2 by 2-hour intravenous (IV) infusion, day 1
The treatment will commence in 4-6 weeks after surgery. Repeat every 21 days for 8 cycles
Sponsors
Hellenic Cooperative Oncology Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent on the trial relevant procedures 2. Histologically confirmed colon adenocarcinoma according to the International Organization Against Cancer (UICC) classification. The tumor must be radically excised. The patients must be histologically in a B2 (high risk) or C stage according to Duke’s. Stage B2 high risk includes: patients with poorly differenciated or mucous tumors, stage T4 tumors, outer-wall vein invasion, obstruction or perforation 3. During surgery at least eight (8) regional lymph nodes should be obtained 4. Absence of any metastatic or residual disease after surgery 5. Enrollment after 4 to 6 weeks after surgery 6. Age of >18 and <75 years 7. Performance status (according to Eastern Cooperative Oncology Group) <2 8. Satisfactory hematological profile, liver and renal function (within 14 days before the beginning of chemotherapy) that are described as follows: - Hematological profile: i. Neutrophils > 2.0x10^9 /L ii. Platelets > 150x10^9 /L iii.Hemoglobin > 10 g/dL - Liver function tests: i. Total bilirubin up to the upper normal limit ii. Serum aspartate aminotransferase (AST) and Serum alanine aminotransferase (ALT) up to 2.5 times the upper normal limit iii. Alkaline phosphatase up to 2.5 times the upper normal limit - Renal function tests: i. Creatinine up to 1.5 times the upper normal limitii. If the creatinine value is higher, the estimated creatinine clearance should be higher than 60 ml/hour 9.Negative pregnancy test (for women of reproductive age)
Exclusion criteria
1. Patients with simultaneous metastasis from the primary tumor that has been totally excised 2. Concomitant therapy with other investigational products 3. Patients that have received previous anticancer therapy 4. Patients that cannot be monitored adequately due to psychological, social, geographic, economic or family reasons 5. Patients who clearly state that they want to enroll in a particular arm of the trial 6. Simultaneous serious disease that affects the participation in the trial 7. Psychiatric or other disorders that do not permit obtaining the informed consent and compliance of the patient to the schedule of the evaluation visits 8. Patients of reproductive age who refuse to take adequate contraceptive measures during the therapy 9. Prior or current history of: chronic diarrhea, inflammatory bowel disease, active peptic ulcer or intestinal bleeding 10. Hypersensitivity to oxaliplatin, capecitabine or to fluoropyrimidines 11. Recent history (last 6 months) of cardiac infarction, coronary disease, serious congestive heart failure, uncontrolled hypertension, non-controlled arrythmias 12. History of other neoplasm with the exception of in situ cervical carcinoma or non-melanoma skin cancer
Outcome results
None listed