Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04592913
Collaborator
(none)
900
175
2
50.9
5.1
0.1
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, Double-blind, Placebo-controlled studyRandomized, Double-blind, Placebo-controlled study
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date
:
Nov 17, 2020
Anticipated Primary Completion Date
:
Feb 14, 2025
Anticipated Study Completion Date
:
Feb 14, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Event-free survival (EFS) [Up to 5 years]
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) [Up to 5 years]
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 [Up to 5 years]
pCR rate is the proportion of patients who have no residual viable tumor in the resected specimens.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 200 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Duarte | California | United States | 91010 |
| 2 | Research Site | Los Angeles | California | United States | 90027 |
| 3 | Research Site | Los Angeles | California | United States | 90095 |
| 4 | Research Site | Sylmar | California | United States | 91342 |
| 5 | Research Site | North Haven | Connecticut | United States | 06473 |
| 6 | Research Site | Fort Myers | Florida | United States | 33901-8101 |
| 7 | Research Site | Saint Petersburg | Florida | United States | 33705 |
| 8 | Research Site | Tallahassee | Florida | United States | 32308 |
| 9 | Research Site | West Palm Beach | Florida | United States | 33401 |
| 10 | Research Site | Atlanta | Georgia | United States | 30322 |
| 11 | Research Site | Fort Wayne | Indiana | United States | 46804 |
| 12 | Research Site | Louisville | Kentucky | United States | 40217 |
| 13 | Research Site | Baton Rouge | Louisiana | United States | 70809 |
| 14 | Research Site | Towson | Maryland | United States | 21204 |
| 15 | Research Site | Boston | Massachusetts | United States | 02215 |
| 16 | Research Site | Detroit | Michigan | United States | 48201 |
| 17 | Research Site | New York | New York | United States | 10028 |
| 18 | Research Site | New York | New York | United States | 10065 |
| 19 | Research Site | Rochester | New York | United States | 14642 |
| 20 | Research Site | Philadelphia | Pennsylvania | United States | 19104 |
| 21 | Research Site | Nashville | Tennessee | United States | 37203 |
| 22 | Research Site | Dallas | Texas | United States | 75390 |
| 23 | Research Site | Lancaster | Texas | United States | 75216 |
| 24 | Research Site | Fairfax | Virginia | United States | 22031 |
| 25 | Research Site | Seattle | Washington | United States | 98109 |
| 26 | Research Site | Buenos Aires | Argentina | C1426ANZ | |
| 27 | Research Site | Buenos Aires | Argentina | C1431FWO | |
| 28 | Research Site | Ciudad Autonoma Buenos Aires | Argentina | 1093 | |
| 29 | Research Site | Ciudad de Buenos Aires | Argentina | 1280 | |
| 30 | Research Site | Rosario | Argentina | 3101 | |
| 31 | Research Site | Rosario | Argentina | S2000DEJ | |
| 32 | Research Site | San Nicolas | Argentina | B2900ACL | |
| 33 | Research Site | Charleroi | Belgium | 6000 | |
| 34 | Research Site | Edegem | Belgium | 2650 | |
| 35 | Research Site | Gent | Belgium | B-9000 | |
| 36 | Research Site | Leuven | Belgium | 3000 | |
| 37 | Research Site | Liège | Belgium | 4000 | |
| 38 | Research Site | Roeselare | Belgium | 8800 | |
| 39 | Research Site | Barretos | Brazil | 14784-400 | |
| 40 | Research Site | Natal | Brazil | 59075-740 | |
| 41 | Research Site | Porto Alegre | Brazil | 90035-903 | |
| 42 | Research Site | Porto Alegre | Brazil | 90050-170 | |
| 43 | Research Site | Porto Alegre | Brazil | 91350-200 | |
| 44 | Research Site | Rio de Janeiro | Brazil | 20231-050 | |
| 45 | Research Site | São José do Rio Preto | Brazil | 15090-000 | |
| 46 | Research Site | São Paulo | Brazil | 01246-000 | |
| 47 | Research Site | Edmonton | Alberta | Canada | t6G1Z2 |
| 48 | Research Site | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 49 | Research Site | North York | Ontario | Canada | M2K 1E1 |
| 50 | Research Site | Oshawa | Ontario | Canada | L1G 2B9, |
| 51 | Research Site | Toronto | Ontario | Canada | M5G 2M9 |
| 52 | Research Site | Montreal | Quebec | Canada | H2X 0A9 |
| 53 | Research Site | Montreal | Canada | H3T 1E2 | |
| 54 | Research Site | La Serena | Chile | 1720430 | |
| 55 | Research Site | Santiago | Chile | 7500653 | |
| 56 | Research Site | Santiago | Chile | 7500921 | |
| 57 | Research Site | Talca | Chile | 3461341 | |
| 58 | Research Site | Temuco | Chile | 4800827 | |
| 59 | Research Site | Temuco | Chile | 4810218 | |
| 60 | Research Site | Aalborg | Denmark | 9000 | |
| 61 | Research Site | København Ø | Denmark | 2100 | |
| 62 | Research Site | Odense C | Denmark | 5000 | |
| 63 | Research Site | Avignon | France | 84918 | |
| 64 | Research Site | Besançon Cedex | France | 25030 | |
| 65 | Research Site | Brest Cedex | France | 29609 | |
| 66 | Research Site | Dijon | France | 21000 | |
| 67 | Research Site | Lyon | France | 69373 | |
| 68 | Research Site | Montpellier | France | 34298 | |
| 69 | Research Site | Nantes | France | 44093 | |
| 70 | Research Site | Nice | France | 06100 | |
| 71 | Research Site | Paris cedex 10 | France | 75475 | |
| 72 | Research Site | Paris cedex 15 | France | 75900 | |
| 73 | Research Site | Paris | France | 75012 | |
| 74 | Research Site | Rennes Cedex 9 | France | 35033 | |
| 75 | Research Site | Berlin | Germany | 13353 | |
| 76 | Research Site | Dresden | Germany | 01307 | |
| 77 | Research Site | Frankfurt | Germany | 60488 | |
| 78 | Research Site | Hamburg | Germany | 20246 | |
| 79 | Research Site | Hamburg | Germany | 20249 | |
| 80 | Research Site | Heidelberg | Germany | 69120 | |
| 81 | Research Site | Heilbronn | Germany | 74078 | |
| 82 | Research Site | Jena | Germany | 7743 | |
| 83 | Research Site | Mainz Am Rhein | Germany | 55131 | |
| 84 | Research Site | München | Germany | 81675 | |
| 85 | Research Site | Schweinfurt | Germany | 97421 | |
| 86 | Research Site | Tübingen | Germany | 72016 | |
| 87 | Research Site | Budapest | Hungary | 1122 | |
| 88 | Research Site | Győr | Hungary | 9024 | |
| 89 | Research Site | Kecskemét | Hungary | 6000 | |
| 90 | Research Site | Szekszárd | Hungary | 7100 | |
| 91 | Research Site | Szolnok | Hungary | 5004 | |
| 92 | Research Site | Chuo-ku | Japan | 104-0045 | |
| 93 | Research Site | Fukuoka-shi | Japan | 810-8563 | |
| 94 | Research Site | Hidaka-shi | Japan | 350-1298 | |
| 95 | Research Site | Hirakata-shi | Japan | 573-1191 | |
| 96 | Research Site | Hiroshima-shi | Japan | 730-8518 | |
| 97 | Research Site | Kashiwa | Japan | 277-8577 | |
| 98 | Research Site | Kitaadachi-gun | Japan | 362-0806 | |
| 99 | Research Site | Kobe-shi | Japan | 650-0047 | |
| 100 | Research Site | Kochi-shi | Japan | 781-8555 | |
| 101 | Research Site | Kurume-shi | Japan | 830-0011 | |
| 102 | Research Site | Nagoya-shi | Japan | 464-8681 | |
| 103 | Research Site | Niigata-shi | Japan | 951-8566 | |
| 104 | Research Site | Ogaki-shi | Japan | 503-8502 | |
| 105 | Research Site | Osaka-shi | Japan | 534-0021 | |
| 106 | Research Site | Osaka-shi | Japan | 541-8567 | |
| 107 | Research Site | Suita-shi | Japan | 565-0871 | |
| 108 | Research Site | Sunto-gun | Japan | 411-8777 | |
| 109 | Research Site | Tokyo | Japan | 135-8550 | |
| 110 | Research Site | Toyoake-shi | Japan | 470-1192 | |
| 111 | Research Site | Wakayama-shi | Japan | 641-8510 | |
| 112 | Research Site | Yamagata-shi | Japan | 990-2292 | |
| 113 | Research Site | Yokohama-shi | Japan | 241-8515 | |
| 114 | Research Site | Anyang-si | Korea, Republic of | 431-070 | |
| 115 | Research Site | Hwasun-gun | Korea, Republic of | 58128 | |
| 116 | Research Site | Seongnam-si | Korea, Republic of | 13620 | |
| 117 | Research Site | Seoul | Korea, Republic of | 03080 | |
| 118 | Research Site | Seoul | Korea, Republic of | 03722 | |
| 119 | Research Site | Seoul | Korea, Republic of | 06351 | |
| 120 | Research Site | Seoul | Korea, Republic of | 06591 | |
| 121 | Research Site | Amsterdam | Netherlands | 1066 CX | |
| 122 | Research Site | Eindhoven | Netherlands | 5623EJ | |
| 123 | Research Site | Rotterdam | Netherlands | 3015GD | |
| 124 | Research Site | Bellavista | Peru | CALLAO 2 | |
| 125 | Research Site | Lima | Peru | LIMA 29 | |
| 126 | Research Site | Lima | Peru | Lima 32 | |
| 127 | Research Site | Lima | Peru | LIMA 34 | |
| 128 | Research Site | San Isidro | Peru | 27 | |
| 129 | Research Site | Bialystok | Poland | 15-027 | |
| 130 | Research Site | Gdańsk | Poland | 80-214 | |
| 131 | Research Site | Kraków | Poland | 30-688 | |
| 132 | Research Site | Poznan | Poland | 60-780 | |
| 133 | Research Site | Poznan | Poland | 61-866 | |
| 134 | Research Site | Warszawa | Poland | 02-034 | |
| 135 | Research Site | Warszawa | Poland | 04-141 | |
| 136 | Research Site | Łódź | Poland | 93-513 | |
| 137 | Research Site | Kaluga | Russian Federation | 248007 | |
| 138 | Research Site | Moscow | Russian Federation | 111123 | |
| 139 | Research Site | Moscow | Russian Federation | 115478 | |
| 140 | Research Site | Moscow | Russian Federation | 125284 | |
| 141 | Research Site | Novosibirsk | Russian Federation | 630108 | |
| 142 | Research Site | Obninsk | Russian Federation | 249036 | |
| 143 | Research Site | Saint-Petersburg | Russian Federation | 195067 | |
| 144 | Research Site | Saint-Petersburg | Russian Federation | 197089 | |
| 145 | Research Site | Barcelona | Spain | 08025 | |
| 146 | Research Site | Barcelona | Spain | 08908 | |
| 147 | Research Site | Barcelona | Spain | 8035 | |
| 148 | Research Site | Madrid | Spain | 28007 | |
| 149 | Research Site | Madrid | Spain | 28034 | |
| 150 | Research Site | Málaga | Spain | 29011 | |
| 151 | Research Site | Ourense | Spain | 32005 | |
| 152 | Research Site | Santander | Spain | 39008 | |
| 153 | Research Site | Sevilla | Spain | 41013 | |
| 154 | Research Site | Valencia | Spain | 46010 | |
| 155 | Research Site | Kaohsiung | Taiwan | 807 | |
| 156 | Research Site | Kaohsiung | Taiwan | 83301 | |
| 157 | Research Site | Taichung | Taiwan | 40443 | |
| 158 | Research Site | Tainan City | Taiwan | 70403 | |
| 159 | Research Site | Taipei | Taiwan | 10048 | |
| 160 | Research Site | Taipei | Taiwan | 112 | |
| 161 | Research Site | Taoyuan City | Taiwan | 333 | |
| 162 | Research Site | Adana | Turkey | 01120 | |
| 163 | Research Site | Ankara | Turkey | ||
| 164 | Research Site | Erzurum | Turkey | 25240 | |
| 165 | Research Site | Istanbul | Turkey | 34098 | |
| 166 | Research Site | İstanbul | Turkey | 34457 | |
| 167 | Research Site | Samsun | Turkey | ||
| 168 | Research Site | Cambridge | United Kingdom | CB2 0QQ | |
| 169 | Research Site | Dundee | United Kingdom | DD1 9SY | |
| 170 | Research Site | Glasgow | United Kingdom | G12 0YN | |
| 171 | Research Site | Leicester | United Kingdom | LE2 7LZ | |
| 172 | Research Site | London | United Kingdom | EC1A 7BE | |
| 173 | Research Site | Manchester | United Kingdom | M20 4BX | |
| 174 | Research Site | Oxford | United Kingdom | OX3 7LE | |
| 175 | Research Site | Surrey | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT04592913
Other Study ID Numbers:
- D910GC00001
- 2019-001555-40
First Posted:
Oct 19, 2020
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms: