Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
Part of paid clinical trials in Duarte, California.
- Sponsor
- AstraZeneca
- Study ID
- NCT04592913
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
- Esophagogastric Junction
- Gastrointestinal Neoplasms
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 200 Years
- Healthy Volunteers
- Not accepted
Interventions
- Durvalumab — DRUGHuman monoclonal antibody
- FLOT chemotherapy — DRUGA combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel
Study Details
This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).
Key Dates
- Start date
- Nov 17, 2020
- Status verified
- Dec 2025
- Primary completion
- Dec 20, 2024
- Completion
- Sep 27, 2027
Study Design
- Enrollment
- 957 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Arm Bplacebo product and FLOT chemotherapy
- Experimental: Arm ADurvalumab and FLOT chemotherapy
Primary Outcome Measure
Event-free survival (EFS) [ Time Frame: Up to 5 years ]
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Duarte | California | 91010 | - |
| Research Site | Los Angeles | California | 90027 | - |
| Research Site | Los Angeles | California | 90095 | - |
| Research Site | Sylmar | California | 91342 | - |
| Research Site | St. Petersburg | Florida | 33705 | - |
| Research Site | Tallahassee | Florida | 32308 | - |
| Research Site | West Palm Beach | Florida | 33401 | - |
| Research Site | Fort Wayne | Indiana | 46804 | - |
| Research Site | Louisville | Kentucky | 40217 | - |
| Research Site | Boston | Massachusetts | 02215 | - |
| Research Site | New York | New York | 10065 | - |
| Research Site | Rochester | New York | 14642 | - |
| Research Site | Nashville | Tennessee | 37203 | - |
| Research Site | Dallas | Texas | 75390 | - |
| Research Site | Lancaster | Texas | 75216 | - |
| Research Site | Seattle | Washington | 98109 | - |
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