Back to resultsAssessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
Primary Purpose
Gastrointestinal Neoplasms, Esophagogastric Junction
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Durvalumab
FLOT chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Neoplasms
Eligibility Criteria
Key Inclusion Criteria:
- Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
- Patients must undergo radical surgery.
- No prior anti-cancer therapy for the current malignancy.
- World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment.
- Adequate organ and marrow function.
- Availability of tumor sample prior to study entry.
- Must have a life expectancy of at least 24 weeks.
Key Exclusion Criteria:
- Patients with peritoneal dissemination or distant metastasis.
- Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
- Contra-indication to any of the study drugs.
- History of allogeneic organ transplantation.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Arm B
Arm A
Arm Description
placebo product and FLOT chemotherapy
Durvalumab and FLOT chemotherapy
Outcomes
Primary Outcome Measures
Event-free survival (EFS)
EFS is the time from date of randomization until the date of disease progression or death.
Secondary Outcome Measures
To compare Arm A relative to Arm B on overall survival (OS)
Overall survival is length of time from randomization until the date of death due to any cause.
To compare Arm A relative to Arm B on pathological complete response (pCR) rate
pCR rate is the proportion of patients who have no residual viable tumor in the resected specimens.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04592913
Brief Title
Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 17, 2020 (Actual)
Primary Completion Date
February 14, 2025 (Anticipated)
Study Completion Date
February 14, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
This study investigates treatment of durvalumab or placebo therapy combined with FLOT chemotherapy (flurouroacil + leucovorin + oxaliplatin + docetaxel) given before surgery (neoadjuvant) and durvalumab or placebo therapy combined with FLOT chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer, and also to better understand the studied disease and associated health problems.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms, Esophagogastric Junction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-blind, Placebo-controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
958 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm B
Arm Type
Placebo Comparator
Arm Description
placebo product and FLOT chemotherapy
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Durvalumab and FLOT chemotherapy
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
Human monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
FLOT chemotherapy
Intervention Description
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel
Primary Outcome Measure Information:
Title
Event-free survival (EFS)
Description
EFS is the time from date of randomization until the date of disease progression or death.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
To compare Arm A relative to Arm B on overall survival (OS)
Description
Overall survival is length of time from randomization until the date of death due to any cause.
Time Frame
Up to 5 years
Title
To compare Arm A relative to Arm B on pathological complete response (pCR) rate
Description
pCR rate is the proportion of patients who have no residual viable tumor in the resected specimens.
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
200 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
Patients must undergo radical surgery.
No prior anti-cancer therapy for the current malignancy.
World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment.
Adequate organ and marrow function.
Availability of tumor sample prior to study entry.
Must have a life expectancy of at least 24 weeks.
Key Exclusion Criteria:
Patients with peritoneal dissemination or distant metastasis.
Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Contra-indication to any of the study drugs.
History of allogeneic organ transplantation.
Facility Information:
Facility Name
Research Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Research Site
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
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Research Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Research Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
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Research Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
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Research Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
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Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
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Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
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Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
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Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
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Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
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Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Research Site
City
Lancaster
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
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Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
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Research Site
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Research Site
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
1093
Country
Argentina
Facility Name
Research Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
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City
Rosario
ZIP/Postal Code
3101
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Argentina
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City
Rosario
ZIP/Postal Code
S2000DEJ
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Argentina
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City
Charleroi
ZIP/Postal Code
6000
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Belgium
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City
Edegem
ZIP/Postal Code
2650
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Belgium
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City
Leuven
ZIP/Postal Code
3000
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Belgium
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City
Liège
ZIP/Postal Code
4000
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Belgium
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City
Roeselare
ZIP/Postal Code
8800
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Belgium
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City
Barretos
ZIP/Postal Code
14784-400
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Brazil
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City
Natal
ZIP/Postal Code
59075-740
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Brazil
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City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
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City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
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City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
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City
São José do Rio Preto
ZIP/Postal Code
15090-000
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Brazil
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City
São Paulo
ZIP/Postal Code
01246-000
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Brazil
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Edmonton
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Alberta
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t6G1Z2
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Canada
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North York
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Ontario
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M2K 1E1
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Canada
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Oshawa
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Ontario
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L1G 2B9,
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Canada
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Toronto
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Ontario
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M5G 2M9
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Canada
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Montreal
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Quebec
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H2X 0A9
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Canada
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Montreal
ZIP/Postal Code
H3T 1E2
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Canada
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City
La Serena
ZIP/Postal Code
1720430
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Chile
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Santiago
ZIP/Postal Code
7500653
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Chile
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Santiago
ZIP/Postal Code
7500921
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Chile
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City
Talca
ZIP/Postal Code
3461341
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Chile
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City
Temuco
ZIP/Postal Code
4800827
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Chile
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Temuco
ZIP/Postal Code
4810218
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Chile
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Aalborg
ZIP/Postal Code
9000
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Denmark
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City
København Ø
ZIP/Postal Code
2100
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Denmark
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Odense C
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5000
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Denmark
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Avignon
ZIP/Postal Code
84918
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France
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Besançon Cedex
ZIP/Postal Code
25030
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France
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City
Brest Cedex
ZIP/Postal Code
29609
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France
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Dijon
ZIP/Postal Code
21000
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France
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Lyon
ZIP/Postal Code
69373
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France
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City
Montpellier
ZIP/Postal Code
34298
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France
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City
Nantes
ZIP/Postal Code
44093
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France
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City
Nice
ZIP/Postal Code
06100
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France
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City
Paris cedex 10
ZIP/Postal Code
75475
Country
France
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City
Paris cedex 15
ZIP/Postal Code
75900
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France
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City
Paris
ZIP/Postal Code
75012
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France
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City
Rennes Cedex 9
ZIP/Postal Code
35033
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France
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City
Berlin
ZIP/Postal Code
13353
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Germany
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City
Dresden
ZIP/Postal Code
01307
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Germany
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City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
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City
Hamburg
ZIP/Postal Code
20246
Country
Germany
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City
Hamburg
ZIP/Postal Code
20249
Country
Germany
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City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
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City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
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City
Jena
ZIP/Postal Code
7743
Country
Germany
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City
Mainz Am Rhein
ZIP/Postal Code
55131
Country
Germany
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City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
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City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
Facility Name
Research Site
City
Tübingen
ZIP/Postal Code
72016
Country
Germany
Facility Name
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City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
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City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Research Site
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Research Site
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
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City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Research Site
City
Hidaka-shi
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Research Site
City
Hirakata-shi
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Research Site
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Research Site
City
Kitaadachi-gun
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
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City
Kochi-shi
ZIP/Postal Code
781-8555
Country
Japan
Facility Name
Research Site
City
Kurume-shi
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
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City
Nagoya-shi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
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City
Niigata-shi
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
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City
Ogaki-shi
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Research Site
City
Suita-shi
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Research Site
City
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Research Site
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Research Site
City
Toyoake-shi
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Research Site
City
Wakayama-shi
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
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City
Hwasun-gun
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Research Site
City
Eindhoven
ZIP/Postal Code
5623EJ
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3015GD
Country
Netherlands
Facility Name
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City
Bellavista
ZIP/Postal Code
CALLAO 2
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 29
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 32
Country
Peru
Facility Name
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City
Lima
ZIP/Postal Code
LIMA 34
Country
Peru
Facility Name
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City
San Isidro
ZIP/Postal Code
27
Country
Peru
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City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
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City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
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City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-780
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
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City
Warszawa
ZIP/Postal Code
02-034
Country
Poland
Facility Name
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City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
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City
Łódź
ZIP/Postal Code
93-513
Country
Poland
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City
Kaluga
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
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City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
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City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
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City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
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City
Novosibirsk
ZIP/Postal Code
630108
Country
Russian Federation
Facility Name
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City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
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City
Saint-Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
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City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
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City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
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City
Barcelona
ZIP/Postal Code
8035
Country
Spain
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City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
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City
Madrid
ZIP/Postal Code
28034
Country
Spain
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City
Málaga
ZIP/Postal Code
29011
Country
Spain
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City
Ourense
ZIP/Postal Code
32005
Country
Spain
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City
Santander
ZIP/Postal Code
39008
Country
Spain
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City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
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City
Valencia
ZIP/Postal Code
46010
Country
Spain
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City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
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City
Taichung
ZIP/Postal Code
40443
Country
Taiwan
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City
Tainan City
ZIP/Postal Code
70403
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Taiwan
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City
Taipei
ZIP/Postal Code
10048
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Taiwan
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City
Taipei
ZIP/Postal Code
112
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Taiwan
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City
Taoyuan City
ZIP/Postal Code
333
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Taiwan
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City
Adana
ZIP/Postal Code
01120
Country
Turkey
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City
Ankara
Country
Turkey
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City
Erzurum
ZIP/Postal Code
25240
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Turkey
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City
Istanbul
ZIP/Postal Code
34098
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Turkey
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City
İstanbul
ZIP/Postal Code
34457
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Turkey
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City
Samsun
Country
Turkey
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City
Cambridge
ZIP/Postal Code
CB2 0QQ
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United Kingdom
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Research Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Research Site
City
Leicester
ZIP/Postal Code
LE2 7LZ
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Research Site
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
35623069
Citation
Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
Results Reference
derived
PubMed Identifier
35535555
Citation
Janjigian YY, Van Cutsem E, Muro K, Wainberg Z, Al-Batran SE, Hyung WJ, Molena D, Marcovitz M, Ruscica D, Robbins SH, Negro A, Tabernero J. MATTERHORN: phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer. Future Oncol. 2022 Jun;18(20):2465-2473. doi: 10.2217/fon-2022-0093. Epub 2022 May 10.
Results Reference
derived
PubMed Identifier
35179774
Citation
Cowzer D, Janjigian YY. Top advances in esophageal/gastroesophageal junction cancers in 2021. Cancer. 2022 May 15;128(10):1894-1899. doi: 10.1002/cncr.34140. Epub 2022 Feb 18. No abstract available.
Results Reference
derived
Learn more about this trial
Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
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