Etude : PANACHE / PRODIGE 48



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : PANACHE

Nom : PRODIGE 48

Traitement : Néoadjuvant

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 10/07/2018
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Essai de phase II multicentrique randomisé évaluant l'intérêt d'une chimiothérapie néoadjuvante par FOLF(IRIN)OX dans les adénocarcinomes pancréatiques résécables

Spécialité : Organes digestifs
Localisation : C25 - Tumeur maligne du pancréas
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : PANACHE-01 is an open, non-comparative, randomised, multicentre Phase II study designed to assess the safety and efficacy of two modes of neo-adjuvant chemotherapy (FOLFIRINOX & FOLFOX) relative to the current reference treatment (surgery and then adjuvant chemotherapy) for resectable PDAC.

Patients with immediately resectable PDAC (definition based on the NCCN's (American National Comprehensive Cancer Network 2014) latest guidelines) will be randomised to either pancreatectomy and adjuvant chemotherapy or 4 cycles of neoadjuvant chemotherapy with either FOLFOX or FOLFIRINOX. The patients in the neoadjuvant chemotherapy arms will receive postoperative chemotherapy for 4 months (8 cycles).

Phase : II

Stade : I à II

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Histology-proven, adenocarcinoma of the pancreas.
- Resectable adenocarcinoma (according to the NCCN classification 2014): absence of distant organ or distal lymph node metastases, absence of evidence of superior mesenteric vein (SMV) and portal vein distortion, tumour thrombus, or venous encasement, the existence of clear fat planes around the celiac axis, hepatic artery and superior mesenteric artery (SMA). Resectability is evaluated on arterial-phase and portal-phase IV contrast-enhanced multislice CT-scan of the pancreas (slice thickness: 2.5 mm), as evaluated in a multidisciplinary staff meeting including at least one radiologist and one expert surgeon.
- No prior chemotherapy.
- Age 18 years or over.
- Ability to understand and willingness to consent to formal requirements for study participation
- Provision of written informed consent prior to any study-specific screening procedures.

Critères de non-inclusion : - PDAC defined as "borderline", locally advanced, non-resectable or metastatic.
- Prior cancer therapy for PDAC
- Surgical or anaesthesiological contra-indications: non-controlled congestive heart failure - non-treated angina - recent myocardial infarction (in the previous year) - non-controlled arterial hypertension (SBP >160 mm or DBP > 100 mm, despite optimal drug treatment), long QT, major non-controlled infection, severe liver failure.
- Any medical, psychological or social situation that (in the investigator's opinion) could limit (i) the patient's compliance with the protocol or (ii) the ability to obtain or interpret data.
- Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception.
- History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1, according to according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0.
- Known hypersensitivity reaction to any of the components of study treatments.
- Pregnancy (the absence of which must be confirmed in a ß-hCG test) or breast-feeding.
- Any significant disease which, in the investigator's opinion, would exclude the patient from the study.
- Patients having been included in a clinical trial within the previous 4 weeks or participating in another trial.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
CHU de Rouen
Type de sponsor : Institutionnel
76000 ROUEN

Coordonnateur :
Llilian SCHWARZ
lilian.schwarz@chu-rouen.fr
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
CHU de Rouen - 1 Rue de Germont - 76000 ROUEN

Investigateur :
Lilian SCHWARZ

TEC / ARC / IDE :
Nathalie BREDA
nathalie.breda@
chu-rouen.fr

Ouverture de l'essai : OUVERT

MAJ : 10/07/2018