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Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer

NCT03764553 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-04-07

No results posted yet for this study

Summary

This is a multi-center, open label, randomized phase II trial for patients with previously untreated metastatic or locally advanced esophagogastric cancer, using a pick the winner design to identify the best combination therapy in terms of progression free survival and neurotoxicity.

Conditions

  • Esophageal Cancer

Interventions

DRUG

Liposomal Irinotecan

Iv liposomal irinotecan

DRUG

Carboplatin

IV Carboplatin

DRUG

Capecitabine

PO Capecitabine

DRUG

Oxaliplatin

IV Oxaliplatin

DRUG

5-fluorouracil

IV 5-fluorouracil

DRUG

Leucovorin

IV Leucovorin

Sponsors & Collaborators

  • Servier

    collaborator INDUSTRY

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Jan M Prins, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2025-07-31
Completion
2026-07-01

Countries

  • Netherlands

Study Locations

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Entities

Drugs
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 NCT03764553 on ClinicalTrials.gov