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A multicenter phase II trial of peri-operative chemotherapy with mFOLFOX6 for resectable liver metastases from colorectal cancer.

ABSTRACT: Interventions: Pre-operative chemotherapy(mFOLFOX6) 4cycles followed by surgical hepatectomy followed by post-operative chemotherapy (mFOLFOX6) 8cycles, mFOLFOX6(L-OHP85mg/m2, Levofolinate200mg/m2, 5-FU/bolus400mg/m2, 5-FU/continuous2,400mg/m2 every 2 weeks) Primary outcome(s): Liver resection rate Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2625119 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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2022-04-28 | GSE201252 | GEO

Project description:Interventions: investigational material(s) Generic name etc : mFOLFOX6 + panitumumab INN of investigational material : Fluorouracil, calcium levofolinate, oxaliplatin, panitumumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Group P; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, panitumumab: 6 mg/kg; mFOLFOX6 + panitumumab combination therapy, once every two weeks control material(s) Generic name etc : mFOLFOX6 + bevacizumab INN of investigational material : Fluorouracil, calcium levofolinate, oxaliplatin, bevacizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Group B; OXA: 85 mg/m2/day 1, l-LV: 200 mg/m2/day 1, 5-FU iv: 400 mg/m2/day 1, 5-FU civ: 2400 mg/m2/day 1-3, bevacizumab: 5 mg/kg; mFOLFOX6 + bevacizumab combination therapy, once every two weeks Primary outcome(s): exploratory Overall survival (OS) Timeframe: Up to approximately 63 months OS obtained in the main study will be stratified by the presence or absence of mutation of tumor-associated genes in tumor tissues at the baseline of the main study evaluate the relationship between OS and gene mutations. OS will be measured as the time from the date of randomization to the date of death due to any causes. Study Design: Exploratory analysis

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