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Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer — LyRICX  

Esophageal Cancer Clinical Trial

Official title:
Liposomal iRInotecan, Carboplatin or oXaliplatin in the First Line Treatment of Esophagogastric Cancer: a Randomized Phase 2 Study

Clinical Trial 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.

Clinical Trial Description

The sample size to identify the best combination therapy is based on the following decision making strategy. With less or even zero neurotoxicity grade 2-4 (defined as worst toxicity), the Nal-IRI plus 5FU/LV (Fluorouracil/leucovorin)combination is expected to outperform the standard combination capecitabine plus oxaliplatin and may also outperform capecitabine plus carboplatin. To compensate for a higher neurotoxicity grade 2-4 level, the capecitabine combinations should demonstrate increased progression free survival (PFS) according to the next schedule. Table 1. Decision making strategy Difference in % neurotoxicity grade 2-4 Compensating Increase in PFS >10 - 30% + 3 months >30 - 50% + 4 months The total number to be included will be 269. Patients will be randomized to respectively the Nal-IRI plus 5FU, the capecitabine plus carboplatin and capecitabine plus oxaliplatin group following a 2:2:1 scheme until 49 patients have been included in the capecitabine plus oxaliplatin group and following a 1:1:0 scheme 10 afterwards for the remaining patients. Taking into account 15% withdrawal of patients from the trial before start of study medication, the investigators will include 310 patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03764553
Study type Interventional
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Hanneke WM van Laarhoven, MD, PhD, PhD
Phone 31 20 5665955
Email h.vanlaarhoven@amc.nl
Status Recruiting
Phase Phase 2
Start date May 1, 2019
Completion date August 1, 2024
View Details
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