A clinical trial to study the effects of two drugs, Folfox and CT-011 in patients with cancer of large intestine.
Ontology highlight
ABSTRACT: Intervention1: CT-011: CT-011 (Monoclonal Antibody), 3.0 mg/kg for days 0, 4, 8, 12, 24, 36, 48, 60, 76 along with the combination of FOLFOX .
Dose Value; 3mg/kg (OD).
Frequency: Every 2 weeks
Route: Intravenous
TOTAL duration of therapy: 32 months
Control Intervention1: Chemotherapy regimens include FOLFOX4 or mFOLFOX6 (5-FU, oxaliplatin: Humanized monoclonal antibody.
Treatment details similar as of Intervention.
Primary outcome(s): The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone. [ Time Frame: 32 months ]Timepoint: Within 32months following the first CT-011 treatment
Study Design: Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
DISEASE(S): Patients With Colorectal Adenocarcinoma Previously Untreated For Metastatic Disease
PROVIDER: 2575782 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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