Metastatic Colorectal Cancer Clinical Trial
Official title:
Personalized Marker-driven Early Switch to Aflibercept in Patients With Metastatic Colorectal Cancer (PERMAD-Trial) - a Multicenter, Multinational, Two Part, Phase II Trial
The primary objective of the two phase PERMAD trial is the evaluation of the impact of a
personalized marker-driven treatment approach with early detection of progression and
modification of treatment on cytokines and angiogenic factors (CAF) and efficacy.
In regard of the two parts, the primary objective of the run-in phase (n=50 patients) with
conventional switch of chemotherapy together with the anti-angiogenic agent is the
determination of a distinct cytokines and angiogenic factor (CAF) profile during treatment
with FOLFOX and bevacizumab, which allows early detection/prediction of progressive disease.
The primary objective of the marker-driven randomized part (n=150 patients) with
marker-driven switch of antiangiogenic agent and maintenance of chemotherapy is the
evaluation of the efficacy of an early marker-driven switch of anti-angiogenic treatment
(bevacizumab to aflibercept)
This is a multicentre, multinational, open labeled, prospective, randomized, controlled phase
II study designed to assess the clinical utility of an early marker driven change of
anti-angiogenic treatment (bevacizumab to aflibercept) maintaining the chemotherapy backbone
until definite radiological progression in first line treatment of patients with metastatic
colorectal cancer. After completing the run in phase of the study, with at least 30 patients
completing their first line treatment (due to progression, secondary resection or toxicity)
and being evaluable for CAF analyses, the results will be reviewed by an Independent Data
Monitoring Committee (IDMC). Based on that review the decision to continue with, modify or
cancel the randomized part will be made.
The primary endpoint of the run-in phase with conventional switch of chemotherapy together
with the anti-angiogenic agent is:
• Progression free survival (PFS1) of first line treatment
The primary endpoint of the randomized part with marker-driven switch of antiangiogenic agent
and maintenance of chemotherapy is:
• Progression free survival rate at 6 months (PFSR@6) after first cycle after randomization.
n/a
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