Clinical trial NCT01804790: Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer
Official title: Randomized Phase III Study Comparing Preoperative Chemoradiotherapy Alone Versus Neoadjuvant Chemotherapy With Folfirinox Regimen Followed by Preoperative Chemoradiotherapy for Patients With Resectable Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer of the Rectum
Keywords: rectum
cancer
locally advanced
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 461
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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+)

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.

Primary outcomes:
measure: disease-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 7 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre hospitalier Universitaire d'Amiens
city: Angers
country: France
facility: ICO - Site Paul Papin
city: Auxerre
country: France
facility: Centre hospitalier d'Auxerre
city: Beauvais
country: France
facility: Centre Hospitalier de Beauvais
city: Besancon
country: France
facility: Institut de Cancérologie de Franche Comté
city: Blois
country: France
facility: Centre Hospitalier de Blois
city: Bobigny
country: France
facility: Hopital Avicenne
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Bordeaux
country: France
facility: Institut Bergonie
city: Caen
country: France
facility: Centre Francois Baclesse
city: La Roche-sur-yon
country: France
facility: Chd de La Roche Sur Yon - Les Oudairies
city: Lille
country: France
facility: Centre Bourgogne
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz
city: Marseille
country: France
facility: Ap Hm - Hopital de La Timone - Adultes
city: Montbeliard
country: France
facility: Institut de Cancérologie de Franche Comté
city: Mougins
country: France
facility: Centre Azuréen de cancérologie
city: Mulhouse
country: France
facility: Hopital Emile Muller
city: Nancy
country: France
facility: centre Alexis Vautrin
city: Nancy
country: France
facility: Polyclinique de Gentilly
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Groupe Hospitalier La Pitie-Salpetriere
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Pringy
country: France
facility: Centre Hospitalier Regional D'Annecy
city: Reims
country: France
facility: Hopital Robert Debre
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint-brieuc
country: France
facility: Clinique Armoricaine de Radiologie
city: Saint-gregoire
country: France
facility: Hopital Saint Gregoire
city: Saint-nazaire
country: France
facility: Clinique Mutualiste de L'Estuaire
city: Saint-pierre
country: France
facility: Centre Hospitalier de la Réunion - Site du GHSR
city: St Herblain
country: France
facility: ICO - Site René Gauducheau
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: centre Alexis Vautrin les Nancy
name: Thierry CONROY, PROF
role: PRINCIPAL_INVESTIGATOR
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.