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

NCT03719924 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-01-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • Servier

    collaborator INDUSTRY

  • Federation Francophone de Cancerologie Digestive

    lead OTHER

Principal Investigators

  • DAVID TOUGERON · PRODIGE 62 - FFCD 1701

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-07
Primary Completion
2024-04-15
Completion
2024-09-29

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03719924 on ClinicalTrials.gov