Clinical

Dataset Information

0

A clinical trial to study the effects of two drugs, Folfox and CT-011 in patients with cancer of large intestine.


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

Similar Datasets

| PRJNA113417 | ENA
2008-06-11 | E-GEOD-10015 | biostudies-arrayexpress
2004-12-20 | GSE1888 | GEO
| 2574628 | ecrin-mdr-crc
| 2577140 | ecrin-mdr-crc
| 29486 | ecrin-mdr-crc
2007-09-14 | E-GEOD-1888 | biostudies-arrayexpress
2021-01-11 | PXD023419 | Pride
| 2601412 | ecrin-mdr-crc
| 2576020 | ecrin-mdr-crc