NCT01804790 · CITED IN SOURCE DOCUMENTS

Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2025-06-12

National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy (CRT), versus preoperative CRT in patients with locally advanced rectal cancer.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: Inclusion Criteria: * Histologically proven rectal adenocarcinoma * Stages cT3 with risk of local recurrence or cT4, M0 and for which a multidisciplinary meeting recommend preoperative CRT * Resectable tumor, or considered as potentially resectable after CRT * No distant metastases * Patient eligible for surgery * Patient aged from 18 to 75 years * World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status 0/2. * No heart failure or coronary heart disease symptoms (even controlled). * No peripheral neuropathy \> grade 1 * No prior radiotherapy of the pelvis for any reason and no previous CT * No major comorbidity that may preclude the delivery of treatment and no active infection (HIV or chronic hepatitis B or C). * Adequate contraception in fertile patients. * Adequate hematologic function * Adequate hepatic function * Signed written informed consent Exclusion Criteria: * Metastatic disease * Unresectable rectal cancer, including prostatic involvement or extension to pelvic floor muscles * Contraindication to 5-FU, or to oxaliplatin or to irinotecan, including Gilbert disease or genotype UGT1A1 * Medical history of chronic diarrhea or inflammatory disease of the colon or rectum * Medical history of angina pectoris or myocardial infarction * Progressive active infection or any other severe medical condition that could jeopardize treatment administration * Other concomitant cancer, or medical history of cancer other than treated in situ cervical carcinoma or basocellular carcinoma or spinocellular carcinoma * Patient included in another clinical trial testing an investigational agent. * Pregnant or breast-feeding woman. * Persons deprived of liberty or under guardianship or incapable of giving consent * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Chemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy/session ; 25 fractions) + capecitabine 800 mg/m² twice daily 5 days/7, excluding weekends), then 6-8 weeks after chemoradiation, surgery with total mesorectal excision (TME), followed by adjuvant chemotherapy for 6 months, either mFolfox6 or capecitabine, depending on the center's choice.
intervention Names
Radiation: Radiotherapy 50 Gy
Drug: Capecitabine
Procedure: TME surgery
Drug: mFolfox6 or capecitabine
label
Arm A : Radiotherapy + capecitabine
type
ACTIVE_COMPARATOR
description
Drug: Chemotherapy mFolfirinox Investigational arm: Neoadjuvant CT mFolfirinox, 6 cycles (ca. 3 months; each cycle = 2 weeks): oxaliplatin: 85 mg/m² in 2 hours at D1 irinotecan: 180 mg/m² in 90 min at D1 folinic acid: 400 mg/m² simultaneously in 2 hours at D1 during the irinotecan infusion 5-fluorouracil (5-FU): 2400 mg/m² continuous infusion during 48 hours (1200 mg/m² at D1 and D2), every 14 days during 2 months (4 cycles). Then followed by 5 weeks of chemoradiotherapy 50 Gy (2 Gy/session, 5 sessions per week) + capecitabine 800 mg/m² twice daily 5 days/7), then surgery with TME 6-8 weeks after chemoradiation, followed by 3 months of adjuvant chemotherapy, either mFolfox6 or capecitabine depending on the center's choice.
intervention Names
Drug: mFolfirinox
Radiation: Radiotherapy 50 Gy
Drug: Capecitabine
Procedure: TME surgery
Drug: mFolfox6 or capecitabine
label
Arm B : Chemotherapy then radiochemotherapy
type
EXPERIMENTAL

interventions

arm Group Labels
Arm B : Chemotherapy then radiochemotherapy
description
Investigational arm: Neoadjuvant chemotherapy mFolfirinox, 4 cycles: oxaliplatin: 85 mg/m² in 2 hours at D1 irinotecan: 180 mg/m² in 90 min at D1 folinic acid: 400 mg/m² simultaneously in 2 hours at D1 during the irinotecan infusion 5-FU: 2400 mg/m² continuous infusion during 48 hours (1200 mg/m² at D1 and D2), every 14 days during 2 months (4 cycles), then CRT (50 Gy (2 Gy/session, 25 fractions) + capecitabine 800 mg/m² twice a day 5 days/7), then surgery with TME 6-8 weeks after chemoradiation, and 4 months of adjuvant CT depending on the center's choice.
name
mFolfirinox
type
DRUG
arm Group Labels
Arm A : Radiotherapy + capecitabine
Arm B : Chemotherapy then radiochemotherapy
description
5 radiations per week of 2 Gy for 5 weeks
name
Radiotherapy 50 Gy
type
RADIATION
arm Group Labels
Arm A : Radiotherapy + capecitabine
Arm B : Chemotherapy then radiochemotherapy
description
1600 mg/m² (800 mg/m² twice daily) for 5 weeks
name
Capecitabine
type
DRUG
arm Group Labels
Arm A : Radiotherapy + capecitabine
Arm B : Chemotherapy then radiochemotherapy
name
TME surgery
type
PROCEDURE
arm Group Labels
Arm A : Radiotherapy + capecitabine
Arm B : Chemotherapy then radiochemotherapy
description
oxaliplatine 85 mg/m² (day 1 of cycle; perfusion in 2h), folinic acid 400 mg/m² (day 1 of cycle perfusion in 2h), 5-FU (bolus 400 mg/m² in 10 min and 2400 mg/m² perfusion continuous 46h). Arm A - 12 cycles ; Arm B - 6 cycles OR Capecitabine 2500 mg/m²/day (Each cycle consists of 1250 mg/m² twice daily for D1-14 then pause therapeutic from D15-21). Arm A - 8 cycles; Arm B 4 cycles.
name
mFolfox6 or capecitabine
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 461
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
To compare the 3-year disease-free survival between the investigational arm and the control arm.
measure
disease-free survival
time Frame
3 years

secondary Outcomes

description
Overall survival will be defined as the time from randomisation to the time of occurrence of the first death regardless to its cause. Patients alive at the time of analysis will be censored at the date of the last follow up.
measure
Overall survival
time Frame
7 years

Full study description

brief Summary: National, multi-center, open-label,randomized, 2-arm phase III superiority trial, comparing neoadjuvant chemotherapy (CT) with mFolfirinox followed by preoperative chemoradiotherapy (CRT), versus preoperative CRT in patients with locally advanced rectal cancer.
detailed Description: Methodology This is a biomedical research, national, multicenter, open-label randomized, 2-arm phase III superiority trial, comparing neoadjuvant CT with mFolfirinox then preoperative CRT, versus immediate preoperative CRT, in patients with locally advanced rectal cancer Randomized Phase III study with stopping rules Stratification : center, gender, tumor location in the rectum (\<6 cm from anal verge versus ≥6 cm), initial stage (cT3 vs cT4, and cN0 vs cN+)

Source references

references

citation
Conroy T, Bosset JF, Etienne PL, Rio E, Francois E, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouche O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardiere C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.
pmid
33862000
type
RESULT