ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Type d'étude
Présentation de l'étude
Acronyme : PANDAS

Nom : PRODIGE 44

Traitement : Néoadjuvant

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 21/08/2018
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase II, randomisée multicentrique, de chimiothérapie néoadjuvante par mFolfirinox, suivie ou non d’une radiochimiothérapie concomitante avant chirurgie d’un adénocarcinome du pancréas à la limite de la résécabilité

Spécialité : Organes digestifs
Localisation : C25 - Tumeur maligne du pancréas
Informations complémentaires
Schéma : Les patients seront randomisés :
- mFolfirinox + chirurgie (Bras A) : poursuite de 2 cures de mFolfirinox complémentaires, puis chirurgie de 4 à 8 semaines après chimiothérapie
- mFolfirinox + radiochimiothérapie concomitante + chirurgie (Bras B) : poursuite de 2 cures de mFolfirinox complémentaires, suivies d'une radiochimiothérapie concomitante : 50,4 Gy (28 fractions, 1,8 GY/séance ; 5 fractions/semaine en technique de RCMI + capécitabine 830 mg/m² matin et soir 5 jours/7), puis chirurgie 4 à 8 semaines après radiochimiothérapie La chirurgie sera réalisée systématiquement chez tous les patients sans métastases, sauf progression tumorale évidente ou critère d'inopérabilité.
Après chirurgie, les patients recevront une chimiothérapie adjuvante par gemcitabine (1000 mg/m² hebdomadaire, 3 semaines sur 4 pendant 12 semaines) ou par LV5FU modifié (une semaine sur deux, 6 cures pendant 12 semaines).

Phase : II

Stade : NA

Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - ECOG performance status 0 or 1
- Adult patients ≥ 18 years and ≤ 75 years of age
- Histologic or cytologic proven adenocarcinoma of the pancreas (histologic confirmation of diagnosis is preferred)
- Confirmation by independent multidisciplinary expert review of borderline resectable status, according to NCCN-Clinical Practice Guidelines in Oncology "pancreatic adenocarcinoma", version 1.2015.
- Adequate hematologic function, as follows:
absolute neutrophil count (ANC) ≥ > 2000/mm3
platelet count ≥ 100 000/mm3
haemoglobin ≥ 10 g/dL

- Adequate renal, hepatic and bone marrow function, defined as:
◦Calculated creatinine clearance ≥ 50 mL/min according to MDRD formula
◦Serum total bilirubin ≤ 1.5 times the institutional upper limit of normal. Patients with a biliary short metal stent due to cancer obstruction may be included provided that high-quality imaging is performed before stenting and bilirubin level after stent insertion decreased to ≤ 20 mg/L (≤ 34 µmol/l), and there is no cholangitis.

- Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner)
◦for male subject: during the treatment and for up to 6 months after the last dose of oxaliplatin or up to 3 months after the last dose of irinotcan.
◦for female subject: during the treatment and for up to 4 months after the last dose of oxaliplatin or up to 3 months after the last dose of irinotcan.

- Ability to provide written informed consent before the start of any study specific procedures
- Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study.

Critères de non-inclusion : - Any previous treatment of the pancreatic cancer except biliary short metal stenting (chemotherapy, targeted tumor therapy, local ablative therapy, previous irradiation within the actual fields of planned radiotherapy)
- Evidence of distant metastases including ascites
- Evidence of extent of pancreatic cancer beyond that defined as "borderline resectable" : suspicious lymphadenopathy outside of the standard field of resection (i.e., aortocaval nodes, distant abdominal nodes)
- Contraindication for pancreas resection
- Pregnant or breast feeding females
- Patients with known Gilbert's Syndrome or homozygosity for UGT1A1*28 polymorphism
- Participation in any other clinical trial or treatment with any experimental drug within 28 days before enrolment to the study or during study participation until the end of treatment visit that can be interfering with the objectives of the study
- Previous or concurrent malignant tumor disease other than underlying tumor disease (with the exception of cervical cancer in situ, adequately treated non-melanoma skin cancers, superficial bladder tumors (Ta, Tis, and T1) or any curatively treated without chemotherapy and favourable prognosis tumors without evidence of disease for > 3 years prior to enrolment)

- Any severe and/or uncontrolled medical conditions including but not limited to:
◦Clinically significant cardiovascular or vascular disease : angina pectoris (even controlled), previous myocardial infarction, serious uncontrolled cardiac arrhythmia, chronic heart failure, acute or chronic infectious disease requiring general treatment)
◦Acute and chronic, active infectious disorders that requires systemic treatment --- Peripheral polyneuropathy > grade 1
◦Any previous inflammatory disease of colon or rectum
◦Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the study and his/her safety during the study e.g. severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders

- Hypersensitivity against any of the study drugs (gemcitabine, oxaliplatin, irinotecan, 5-fluorouracil, folinic acid), or the ingredients of these drugs (e.g. fructose).
Informations relatives au promoteur
Promoteur :
Type de sponsor : Institutionnel
6 avenue de Bourgogne CS 30519 - 54519 Vandœuvre-lès-Nancy Cedex
54000 NANCY

Coordonnateur :
Thierry CONROY
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
CHU de Rouen - 1 Rue de Germont - 76000 ROUEN

Investigateur :

Nathalie BREDA

Ouverture de l'essai : OUVERT

MAJ : 21/08/2018