Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT03764553
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liposomal Irinotecan — DRUG
    Iv liposomal irinotecan
  • Carboplatin — DRUG
    IV Carboplatin
  • Capecitabine — DRUG
    PO Capecitabine
  • Oxaliplatin — DRUG
    IV Oxaliplatin
  • 5-fluorouracil — DRUG
    IV 5-fluorouracil
  • Leucovorin — DRUG
    IV Leucovorin

Study Details

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.

Key Dates

Start date
May 1, 2019
Status verified
Apr 2026
Primary completion
Jul 31, 2025
Completion
Jul 1, 2026

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liposomal irinotecan, leucovorin and 5FU
    IV Nal-IRI 80 mg/m² (expressed as irinotecan hydrochloride (HCl) salt), folinic acid 400 mg/m², fluorouracil 2400 mg/m² over 46 h, every 2 weeks. No addition of nivolumab is possible for this arm
  • Experimental: Carboplatin and capecitabine
    IV and PO Capecitabine 1000 mg/m2 and carboplatin area under the curve (AUC5), every three weeks. In case of PD-L1 CPS ≥5 only: nivolumab, dose according to local standard, iv day 1
  • Experimental: oxaliplatin and capecitabine
    IV and PO Capecitabine 1000 mg/m2 and oxaliplatin 130 mg/m2, every three weeks. In case of PD-L1 CPS ≥5 only: nivolumab, dose according to local standard, iv day 1

Primary Outcome Measure

Progression free survival [ Time Frame: 42 months ]

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