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A randomized, controlled, open-label multicenter trial to assess the safety and efficacy of 3 oxaliplatin-fluoropyrimidine containing regimens (mFOLFOX6; bFOL; XELOX) + Bevacizumab (TREE1 and TREE2) as first line therapy of advanced metastatic colorectal cancer.
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Inclusion and exclusion criteria
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
INCLUSION CRITERIA:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Histologically documented adenocarcinoma of the colon, rectum or appendix.
Metastatic/recurrent disease not amenable to potentially curative treatment (e.g., inoperable metastatic disease).
No prior chemotherapy for metastatic/recurrent disease. Prior adjuvant treatment with 5-FU/LV and/or IFL is allowed if it is completed at least 6 months before study registration.
ECOG Performance Status 0- 1.
At least one unidimensionally measurable lesion with a diameter >/= 20 mm using conventional CT or MRI scans or >/= 10 mm using spiral CT scans. If a single lesion is identified as the target lesion, a histological or cytological confirmation of adenocarcinoma is required.
Recovery in full from any previous surgical procedure.
No other serious concomitant disease.
Required baseline laboratory parameters:
EXCLUSION CRITERIA:
The presence of any of the following will exclude a subject from study enrollment:
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Data sourced from clinicaltrials.gov
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