Decision for adjuvant treatment in stage II colon cancer based on circulating tumor DNA:The CIRCULATE-PRODIGE 70 trial - Archive ouverte HAL Access content directly
Journal Articles Digestive and Liver Disease Year : 2020

Decision for adjuvant treatment in stage II colon cancer based on circulating tumor DNA:The CIRCULATE-PRODIGE 70 trial

(1) , (2, 3) , (1) , (4) , (5) , (4) , (6) , (4) , (7) , (8) , (4, 8) , (9, 10)
1
2
3
4
5
6
7
8
9
10

Abstract

Background: Adjuvant treatment for stage II colon cancer remains debated. Finding a tool to select patients at risk for disease recurrence may help the clinical decision. Circulating tumor DNA (ctDNA) has been reported recently as a potential predictive marker for disease recurrence. We thus aim to test its ability to better select stage II colon cancer patients for adjuvant therapy. Methods: This national, phase III trial (NCT00002019-000935-15) conducted in more than 100 centers in France, plans to screen around 2640 patients in order to randomize (2:1; minimization method) 198 ctDNA positive patients. Patients aged 18 to 75 years with ECOG performance status ≤1 with R0 surgical resection of a pT3-T4aN0 colon or high rectum adenocarcinoma will be randomized within 63 days after curative-intent surgery, to adjuvant mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², and 5-FU bolus 400 mg/m2 then 5FU Continuous infusion 2.4 g/m²) every two weeks for 12 cycles or observation. Patients will be followed for maximum 7 years. A gain of 17.5% in 3-yr disease free survival (DFS) is expected (42.5% in the experimental arm vs. 25% in the control arm; HR:0.62; α, 5% [two-sided log-rank test]; 1-β, 80%). Secondary endpoints include 2-yr DFS, overall survival, and toxicity. Recruitement began End of January 2020.
Fichier principal
Vignette du fichier
CIRCULATE_Design paper_DLD_Accepted paper.pdf (192.42 Ko) Télécharger le fichier
Origin : Files produced by the author(s)
Loading...

Dates and versions

inserm-02992943 , version 1 (10-11-2020)

Identifiers

Cite

Julien Taïeb, Léonor Benhaim, Pierre Laurent Puig, Karine Le Malicot, Jean François Emile, et al.. Decision for adjuvant treatment in stage II colon cancer based on circulating tumor DNA:The CIRCULATE-PRODIGE 70 trial. Digestive and Liver Disease, 2020, 52 (7), pp.730-733. ⟨10.1016/j.dld.2020.04.010⟩. ⟨inserm-02992943⟩
109 View
290 Download

Altmetric

Share

Gmail Facebook Twitter LinkedIn More