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An open-label randomized phase III study of capecitabine in combination with oxaliplatin (XELOX) versus fluorouracil/leucovorin as adjuvant therapy for patients who have undergone surgery for colon carcinoma (Dukes stage C) Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on An open-label randomized phase III study of capecitabine in combination with oxaliplatin (XELOX) versus fluorouracil/leucovorin as adjuvant therapy for patients who have undergone surgery for colon carcinoma (Dukes stage C) conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. An open-label randomized phase III study of capecitabine in combination with oxaliplatin (XELOX) versus fluorouracil/leucovorin as adjuvant therapy for patients who have undergone surgery for colon carcinoma (Dukes stage C) Clinical research trials and An open-label randomized phase III study of capecitabine in combination with oxaliplatin (XELOX) versus fluorouracil/leucovorin as adjuvant therapy for patients who have undergone surgery for colon carcinoma (Dukes stage C) health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like An open-label randomized phase III study of capecitabine in combination with oxaliplatin (XELOX) versus fluorouracil/leucovorin as adjuvant therapy for patients who have undergone surgery for colon carcinoma (Dukes stage C). An open-label randomized phase III study of capecitabine in combination with oxaliplatin (XELOX) versus fluorouracil/leucovorin as adjuvant therapy for patients who have undergone surgery for colon carcinoma (Dukes stage C) Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a An open-label randomized phase III study of capecitabine in combination with oxaliplatin (XELOX) versus fluorouracil/leucovorin as adjuvant therapy for patients who have undergone surgery for colon carcinoma (Dukes stage C) clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their An open-label randomized phase III study of capecitabine in combination with oxaliplatin (XELOX) versus fluorouracil/leucovorin as adjuvant therapy for patients who have undergone surgery for colon carcinoma (Dukes stage C) condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.

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An open-label randomized phase III study of capecitabine in combination with oxaliplatin (XELOX) versus fluorouracil/leucovorin as adjuvant therapy for patients who have undergone surgery for colon carcinoma (Dukes stage C)



An open-label randomized phase III study of capecitabine in combination with oxaliplatin (XELOX) versus fluorouracil/leucovorin as adjuvant therapy for patients who have undergone surgery for colon carcinoma (Dukes stage C)

For Condition: Colorectal Cancer
Status: Recruiting
Sponsor(s): Hoffmann-La Roche ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 Enrollment: 

Location and Contact Information:


Additional Information:
Study ID Numbers:
  NO16968; 
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069121

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An open-label randomized phase III study of capecitabine in combination with oxaliplatin (XELOX) versus fluorouracil/leucovorin as adjuvant therapy for patients who have undergone surgery for colon carcinoma (Dukes stage C)

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