Spots Global Cancer Trial Database for Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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