A phase III clinical trial comparing the combination of capecitabine and oxaliplatin (XELOX) versus the combination of fluorouracil (5FU)/leucovorin (LV) and oxaliplatin (FOLFOX) as an adjuvant therapy in patients with operated colorectal cancer of stages B2 (high risk) and C (according to Duke's)
- Conditions
- colorectal cancerCancer - Bowel - Back passage (rectum) or large bowel (colon)
- Registration Number
- ACTRN12610000509066
- Lead Sponsor
- Hellenic Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 824
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the 3-year DFS (disease free survival) between the two group therapies [Xeloda and Oxaliplatin (XELOX) versus 5-FU/Leucovorin and Oxaliplatin (FOLFOX)] in patients with colorectal cancer of stage B2 (high risk) and C, according to Dukes[Disease-free survival will be assessed in each patient by history and physical examination at each cycle and by history, physical examination, serum tumor markers [Carcinoembryonic Antigen (CEA), Carbohydrate Antigen 19-9 (CA19-9)], computed tomography of the abdomen and pelvis and chest x-rays every 4 months and endoscopy every 1 year during follow-up. The final outcome will be assessed 3 years after the enrollment of the last patient at the study.]
- Secondary Outcome Measures
Name Time Method