Rationale and Design of the IROCAS Study: Multicenter, International, Randomized Phase 3 Trial Comparing Adjuvant Modified (m) FOLFIRINOX to mFOLFOX6 in Patients With High-Risk Stage III (pT4 and/or N2) Colon Cancer-A UNICANCER GI-PRODIGE Trial.
Humans
Adenocarcinoma
/ drug therapy
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Chemotherapy, Adjuvant
/ methods
Colonic Neoplasms
/ drug therapy
Disease-Free Survival
Fluorouracil
/ therapeutic use
Irinotecan
/ therapeutic use
Leucovorin
/ therapeutic use
Neoplasm Staging
Organoplatinum Compounds
/ therapeutic use
Oxaliplatin
/ therapeutic use
Survival Rate
Randomized Controlled Trials as Topic
Multicenter Studies as Topic
Clinical Trials, Phase III as Topic
5-FU
Adjuvant
Colon cancer
Irinotecan
oxaliplatin
Journal
Clinical colorectal cancer
ISSN: 1938-0674
Titre abrégé: Clin Colorectal Cancer
Pays: United States
ID NLM: 101120693
Informations de publication
Date de publication:
03 2019
03 2019
Historique:
received:
29
05
2018
revised:
25
09
2018
accepted:
26
09
2018
pubmed:
13
11
2018
medline:
20
7
2019
entrez:
13
11
2018
Statut:
ppublish
Résumé
According to the IDEA trial, 6-month adjuvant chemotherapy should remain the treatment standard in stage III T4 or N2 colon cancer. The relatively poor survival in this high-risk subgroup-a 3-year disease-free survival (DFS) rate of 65%-and the potential synergistic efficacy of 5-fluorouracil (5-FU), oxaliplatin, and irinotecan suggest that FOLFIRINOX may be a regimen of particular interest in this setting. This multicenter international phase 3 trial (ClinicalTrials.gov NCT02967289) being conducted in 49 centers in France and Canada plans to randomize (1:1; minimization method) 640 patients aged 18 to 70 years with Eastern Cooperative Oncology Group performance status ≤ 1. Randomization occurs within 42 days (with treatment initiated within 56 days) after curative-intent R0 surgical resection of a pT4N1 or pT1-4N2 colon adenocarcinoma. Patients will be randomized to receive adjuvant modified FOLFIRINOX (oxaliplatin 85 mg/m
Sections du résumé
BACKGROUND
According to the IDEA trial, 6-month adjuvant chemotherapy should remain the treatment standard in stage III T4 or N2 colon cancer. The relatively poor survival in this high-risk subgroup-a 3-year disease-free survival (DFS) rate of 65%-and the potential synergistic efficacy of 5-fluorouracil (5-FU), oxaliplatin, and irinotecan suggest that FOLFIRINOX may be a regimen of particular interest in this setting.
PATIENTS AND METHODS
This multicenter international phase 3 trial (ClinicalTrials.gov NCT02967289) being conducted in 49 centers in France and Canada plans to randomize (1:1; minimization method) 640 patients aged 18 to 70 years with Eastern Cooperative Oncology Group performance status ≤ 1. Randomization occurs within 42 days (with treatment initiated within 56 days) after curative-intent R0 surgical resection of a pT4N1 or pT1-4N2 colon adenocarcinoma. Patients will be randomized to receive adjuvant modified FOLFIRINOX (oxaliplatin 85 mg/m
Identifiants
pubmed: 30415988
pii: S1533-0028(18)30259-7
doi: 10.1016/j.clcc.2018.09.011
pii:
doi:
Substances chimiques
Fluorouracil
U3P01618RT
folfirinox
0
Irinotecan
7673326042
Leucovorin
Q573I9DVLP
Organoplatinum Compounds
0
Oxaliplatin
04ZR38536J
Banques de données
ClinicalTrials.gov
['NCT02967289']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e69-e73Informations de copyright
Copyright © 2018 Elsevier Inc. All rights reserved.