Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
Study identifier:D910GC00001
ClinicalTrials.gov identifier:NCT04592913
EudraCT identifier:2019-001555-40
CTIS identifier:N/A
Recruitment Complete
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients with Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC)
Medical condition
Gastrointestinal Neoplasms
Phase
Phase 3
Healthy volunteers
No
Study drug
Durvalumab, FLOT chemotherapy
Sex
All
Actual Enrollment
958
Study type
Interventional
Age
18 Years - 200 Years
Date
Study Start Date: 17 Nov 2020
Estimated Primary Completion Date: 31 Oct 2025
Estimated Study Completion Date: 27 Sept 2027
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Arm B placebo product and FLOT chemotherapy | Drug: FLOT chemotherapy A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel |
| Experimental: Arm A Durvalumab and FLOT chemotherapy | Drug: Durvalumab Human monoclonal antibody Drug: FLOT chemotherapy A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel |
