XELOX versus fluorouracil/leucovorin as therapy for surgery in association with colon carcinoma

The primary purpose of the study is to show that the combination of capecitabine plus oxaliplatin (XELOX) is better than the combination of fluorouracil/leucovorin (5-FU/LV) in terms of time to cancer relapse or death in patients who have had surgery for colon cancer (Dukes stage C) and have not received previous chemotherapy for their colon cancer.

Official Title

XELOX versus fluorouracil/leucovorin as adjuvant therapy for patients who have undergone surgery for colon carcinoma (Dukes stage C)

Conditions

– Colorectal Cancer

Study Type

Interventional

Study Design

Treatment

Further Details

Study Start

Eligibility & Criteria

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria Inclusion Criteria:Men or women at least 18 years old with good performance status Histologically confirmed colon carcinoma (Dukes stage C) At least one positive lymph node Operated with curative intent and with no evidence for remaining tumor No evidence of metastatic disease Life expectancy of at least 5 years Informed consent Exclusion Criteria:Women who are pregnant or breast-feeding Women of childbearing potential, with a positive or no pregnancy test Sexually active men and women (of childbearing potential) unwilling to practice contraception during treatment Previous chemotherapy, radiotherapy or immunotherapy for the current colon cancer Not completely recovered from surgery History of another cancer within the last five years,except basal cell skin cancer or cancer of cervix History of uncontrolled seizures Central nervous disorders Clinically significant cardiac disease or myocardial infarction within the last year Gastrointestinal problems such as poor absorption of nutrients or inability to digest tablets Certain forms of pneumonia or lung disease Peripheral neuropathy Organ transplants Serious uncontrolled infections Moderate or severe kidney disease Certain laboratory values Prior unanticipated severe reaction to fluoropyrimidine therapy Known DPD deficiency Allergy to platinum compounds or study medications Received another experimental drug or procedure in the past 4 weeks

Total Enrolment

Contact Details

[1] Hoffmann-La Roche[2] Perth, 6008, Australia