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kzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
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:2023-507338-26-00
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
957
Study type
Interventional
Age
18 Years - 200 Years
Date
Study Start Date: 17 Nov 2020
Primary Completion Date: 20 Dec 2024
Estimated Study Completion Date: 27 Sept 2027
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
Taipei, Taiwan, Province of China, 112
Location
Research Site
Taoyuan City, Taiwan, Province of China, 333
Location
Research Site
kaohsiung, Taiwan, Province of China, 807
Location
Research Site
Tainan City, Taiwan, Province of China, 70403
Location
Research Site
Seoul, Republic of Korea, 03080
Location
Research Site
Kecskemét, Hungary, 6000
Location
Research Site
Szekszárd, Hungary, 7100
Location
Research Site
Szolnok, Hungary, 5004
| 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 |
"There is no result for the study"
Contacts
Contact
AstraZeneca Clinical Study Information Center
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hOOU56EiQQwzYiEgvA%2F1WSUkzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
