Xeloda Maintenance Versus BSC in Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT02060669|
Recruitment Status : Terminated (others)
First Posted : February 12, 2014
Last Update Posted : April 27, 2017
Colorectal cancer (CRC) accounts for 10% to 15% of all cancers and is the second leading cause of cancer deaths in Western countries. Approximately half of all patients develop metastatic disease and become candidates for the palliative chemotherapy which has been proved to prolong survival and improve quality of life (QOL) in patients with metastatic CRC. The most active chemotherapy regiments include oxaliplatin or irinotecan combined with fluoropyrimidines.
With overall survival in metastatic CRC nowadays routinely around 2 years, the same intensity of therapy can hardly be maintained throughout the course of therapy. The continuum of care therefore mandates changes in therapy, with treatment breaks or phases of less-intensive maintenance therapy interspersed with periods of more-intensive therapy to control tumor progression. Thereby, chemo-holidays conceivably reduce the cumulative toxicities of chemotherapy, potentially prevent the unplanned, premature discontinuation of therapy, preserve the ability to administer further phases of therapy, potentially maximize the time on therapy, reduce cost, and could increase QOL for patients. Several trials have tested the influence of chemo-holidays on patient outcome, with various rules on when to stop which component of antitumor therapy as follows; 1) Completely stopping all therapeutic agents, giving patients a completely chemotherapy-free interval (OPTIMOX-2, GISCAD), or 2) Stopping only those agents associated with significant (cumulative) toxicity while continuing other agents as maintenance therapy (OPTIMOX-1, Combined Oxaliplatin Neurotoxicity Prevention Trial [CONcePT]).
Therefore, we'd like to test if capecitabine maintenance after 8 cycles of capecitabine combine with oxaliplatin (XELOX) could prolong progression-free survival without deterioration of QOL and toxicities in patients metastatic CRC.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: Xeloda||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Trial of XELOX (Xeloda/Oxaliplatin) Followed by Xeloda Maintenance Versus Best Supportive Care (BSC) in Metastatic Colorectal Cancer|
|Actual Study Start Date :||June 20, 2010|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Arm 1
No Intervention: Arm 2
best supprotive care
- Progression free survival [ Time Frame: up to 6weeks ]
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): NCT02060669
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Joon Oh Park, M.D.||Samsung Medical Center|