Xeloda Maintenance Versus BSC in Metastatic Colorectal Cancer
Status:
Terminated
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
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.