Etude : OESIRI / PRODIGE 62



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.


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

Nom : PRODIGE 62

Traitement : Métastasique ou localement avancé

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 02/07/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase II randomisée dans le traitement de 2ème ligne de patients atteints de carcinime épidermoïde de l’œsophage métastatique ou localement avancé.

Spécialité : Organes digestifs
Localisation : C15 - Tumeur maligne de l'oesophage
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The aim of our study is to evaluate the efficacy and safety of NALIRI plus 5FU versus paclitaxel as a second-line therapy in patients with locally advanced or metastatic ESCC who had failed to cisplatin- or oxaliplatin-based first-line chemotherapy.
The hypotheses are as follows:
H0: the percentage of patients alive at 9 months of 40% is not useful. H1: the percentage of patients alive at 9 months of 60% is expected.

Principal objective: To evaluate the survival of patients at 9 months

Secondary objectives:
- Progression-free survival (PFS) (clinical and/or radiological)
- Overall survival (OS)
- Best response rate during treatment according to RECIST 1.1 criteria (according to the investigator and the centralised review committee)
- Toxicity (NCI CTC 4.0)
- Quality of life (QLQ-C30 and OES18 questionnaires of the EORTC)


Study Arms :

- Experimental: arm A: ONIVYDE
ONIVYDE ONIVYDE will be administered first, followed by folinic acid or L-folinic acid and then 5-FU at D1 and D14 ONIVYDE: 80 mg/m² intravenous over 90 minutes Folinic acid: 400 mg/m² intravenous over 30 minutes or L-folinic acid (racemic form L) 200 mg/m² over 30 minutes 5-FU: 2400 mg/m² over 46 hours

- Active Comparator: Arm B: TAXOL
TAXOL Premedication consists of corticosteroids, H1 antihistamines and H2 antagonists during 30 minutes at time 1 hour before chemotherapy One cycle every 28 days (D1=D28) 80 mg/m2 IV over 60 minutes at D1, D8 and D15

Phase : II

Stade : Localement avancé à Métastatique

2
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Histologically proven metastatic oesophageal squamous cell carcinoma
Patient in failure with 1st-line treatment with oxaliplatin or cisplatin. Patients presenting with resectable disease treated with surgery or neoadjuvant or adjuvant chemotherapy with oxaliplatin or cisplatin (with or without radiotherapy) can be included if a recurrence has occurred less than 6 months after the end of treatment
- Age ≥ 18 years
- Unresectable disease, measurable or not, according to RECIST 1.1 criteria
- WHO performance status ≤ 2
- Neutrophils ≥ 1500/mm3 (without use of haematopoietic growth factors), platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dl (blood transfusions are authorised for patients with a haemoglobin less than 9 g/dl)
- Total bilirubin ≤ 2 x ULN (biliary drainage is authorised in case of a biliary obstruction); albumin ≥ 25 g/L; AST ≤ 2.5 x ULN, and ALT ≤ 2.5 x ULN (≤ 5 x ULN in case of hepatic metastases)
- Creatinine clearance ≥ 50 ml/min according to MDRD formula
- A normal ECG or ECG with no clinically significant findings
- Patient able to understand and to sign the informed consent form (or who has a legal guardian able to do so for him/him)
- Women of childbearing potential must have a negative pregnancy blood or urine test within 7 days prior to inclusion
- Women of childbearing potential, as well as men (who have sexual relations with women of childbearing potential) must agree to use an effective method of contraception throughout this study and during the 6 months following administration of the last dose of the study medicinal product
- Patient who is a beneficiary of the Social security system
- Patient for whom regular follow-up is possible.

Critères de non-inclusion : - Known brain or bone metastases
- Clinically significant gastrointestinal disorders, including hepatic, haemorrhagic, inflammatory, obstructive disorders or diarrhoea > grade 1
- History of chronic inflammatory bowel disease
- Gilbert's syndrome
- Interstitial lung disease
- Treatment with St John's Wort
- Medical history of Whipple procedure
- Body mass index < 18.5 kg/m2
- Combination with sorivudine and others analogues as brivudine (irreversibly inhibits the enzyme dihydropyrimidine dehydrogenase)
- History of progressive cancer or in remission of less than 3 years duration (patients who present with a cancer in situ or basal cell or squamous cell skin cancer during the last 3 years are eligible).
- Severe arterial thromboembolic events (myocardial infarction, unstable angina, stroke) less than 3 months before inclusion
NYHA class III or IV congestive heart failure, ventricular arrhythmia or uncontrolled blood pressure
- Significant neuropathy ≥ grade 2 according to NCI CTCAE criteria (National Cancer Institute Common Terminology Criteria for Adverse Events) v.4.0.
Known hypersensitivity or allergy to a component of the medicinal products used in the study.
- Known DPD deficiency
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03719924
Promoteur :
Fédération Francophone de Cancérologie Digestive
Type de sponsor : Institutionnel
21000 DIJON

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier de Boulogne-sur-Mer - 33 rue Jacques Monod - 62200 BOULOGNE SUR MER

Investigateur :
Docteur Vincent BOURGEOIS

TEC / ARC / IDE :
Marion BRUMENT
m.brument@
ch-boulogne.fr
03.21.99.39.04

Ouverture de l'essai : OUVERT

MAJ : 16/01/2019

Centre investigateur :
Centre Hospitalier de Lens - 99 Route de la Bassée - 62300 LENS

Investigateur :
Docteur Fabienne WATELLE

TEC / ARC / IDE :
Séverine WADOUX
Severine.WADOUX@
CHRU-LILLE.FR
06.03.64.80.47

Ouverture de l'essai : OUVERT

MAJ : 05/04/2019