Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00002893|
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 13, 2004
Last Update Posted : December 19, 2013
RATIONALE: Palliative chemotherapy may help patients with advanced colorectal cancer live longer and more comfortably.
PURPOSE: Randomized phase III trial to compare the effectiveness of and quality of life following three different palliative chemotherapy regimens in treating patients with advanced metastatic or recurrent colorectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: fluorouracil Drug: leucovorin calcium Drug: raltitrexed||Phase 3|
OBJECTIVES: I. Compare the survival and quality of life of patients with metastatic or recurrent colorectal cancer receiving palliative therapy with leucovorin/fluorouracil vs. continuous-infusion fluorouracil vs. ICI D1694. II. Compare the survival and quality of life of patients with stable or responding disease after 12 weeks of initial treatment randomized to receive 12 additional weeks of chemotherapy vs. no further treatment.
OUTLINE: This is a randomized study. Patients are stratified by participating institution. Patients are randomized to one of three treatment regimens. The first group receives leucovorin followed by fluorouracil every 14 days for a total of 6 courses. The second group receives continuous-infusion fluorouracil for 12 weeks. The third group receive ICI D1694 every 21 days for a total of 4 courses. Patients without progressive disease or excessive toxicity after 12 weeks of treatment are then randomized to receive continuing chemotherapy in 12 weekly cycles of their assigned chemotherapy or to proceed to observation with no further therapy, until evidence of disease progression. Patients are followed every 6 weeks.
PROJECTED ACCRUAL: A total of 900 patients will be entered.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Official Title:||CHEMOTHERAPY CHOICES IN ADVANCED COLORECTAL CANCER: A RANDOMISED TRIAL COMPARING 2 DURATIONS AND 3 SYSTEMIC CHEMOTHERAPY REGIMENS IN THE PALLIATIVE TREATMENT OF ADVANCED COLORECTAL CANCER|
|Study Start Date :||June 1995|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002893
|Cardiff, Wales, United Kingdom, CF4 7XL|
|Study Chair:||Timothy Maughan, MD||Velindre NHS Trust|