Colorectal Cancer Metastatic Clinical Trial
Official title:
Metronomic Chemotherapy With Anti-angiogenic Effect as Maintenance Treatment for Metastatic Colorectal Carcinoma Following Response to FOLFIRI+Bevacizumab: Clinical and Laboratory Studies
Colorectal cancer patients with metastases (mCRC) at response under expensive chemotherapy
which may be toxic +/- exhausting are candidates for an effective and more convenient
maintenance treatment.
Objectives:
1. To define the efficacy of maintenance chemotherapy by a low-dose metronomic (LDM)
regimen, in metastatic CRC patients responding under FOLFIRI + bevacizumab.
2. To discover predictive factors for response to this LDM regimen.
Hypothesis:
1. The re-growth of residual metastases can be slowed by the anti-angiogenic effects of
LDM chemotherapy.
2. Serial measurements of angiogenic/ inflammatory factors in the plasma and/or evaluation
of certain enzymes in the tumor may discover predictive factors of response to LDM
chemotherapy in metastatic CRC patients.
At entry to the research protocol the up-till then administered treatment with Intra Venous FOLFIRI+BEVACIZUMAB will be stopped.Instead, the research oral treatment will be initiated to be taken daily on an ambulatory basis and under once monthly re-evaluation. If and when disease progresses the original FOLFIRI+BEVACIZUMAB treatment will be considered for re-institution. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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