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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 References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about 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 devoted 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) healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as 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 volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated 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 frequently obtain the most expert 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. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.

Home > "A" Clinical Trials Conditions > 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)



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

Other Colorectal Cancer Studies:
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3. Open-label randomized phase 3 study of capecitabine in combo with XELOX vs fluorouracil/leucovorin w/ oxaliplatin (FOLFOX4) as treatment for pts w/ metastatic colorectal cancer, who've received prior treatment w/ CPT-11 in combo w/ fluorouracil/leucovorin as first line therapy

4. Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors

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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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