NCT03719924

Nal-iri/lv5-fu Versus Paclitaxel as Second Line Therapy in Patients With Metastatic Oesophageal Squamous Cell Carcinoma

Nal-IRI/LV5-FU VERSUS PACLITAXEL AS SECOND-LINE THERAPY IN PATIENTS WITH METASTATIC OESOPHAGEAL SQUAMOUS CELL CARCINOMA A Multi-centre, Randomized, Non-comparative Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Federation Francophone de Cancerologie Digestive · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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) Arm A (experimental arm): Nal IRI plus LV5-FU (D1=D28) Nal-IRI: 70 mg/m² intravenous over 90 minutes Followed by intravenous folinic acid 400 mg/m² over 30 minutes or L-folinic acid: 200 mg/m² over 30 minutes And then 5-FU 2,400 mg/m² over 46 hours on D1 to D14 Arm B (control arm): PACLITAXEL (D1=D28) Paclitaxel: 80 mg/m² at D1, D8 and D15 Patients will be randomized in a 1:1 ratio using the minimisation technique. Randomisation will be stratified based on the following factors: * Centre * WHO performance status: 0/1 versus 2 An analysis of circulating tumour DNA (using genetic mutations, in particular, TP53, and DNA methylation analyses) will be performed before the 1st cycle of treatment and at D28, in order to look for factors predictive of response to treatment (decrease in unbound DNA).

Conditions

• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Onivyde	onivyde will be administered first, followed by folinic acid or L-folinic acid and then 5-FU at D1 and D14.
DRUG	Paclitaxel	Paclitaxel : 80 mg/m2 IV during 60 minutes at D1, D8 and D15

Timeline

• Start date: 2019-03-07
• Primary completion: 2024-04-15
• Completion: 2024-09-29
• First posted: 2018-10-25
• Last updated: 2025-01-08

Locations

9 sites across 1 country: France