ClinicalTrials.gov

History of Changes for Study: NCT04592913
Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
Latest version (submitted October 3, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 October 13, 2020 None (earliest Version on record)
2 December 21, 2020 Recruitment Status, Contacts/Locations, Study Status and Oversight
3 February 9, 2021 Contacts/Locations, Study Status, Eligibility and Oversight
4 March 19, 2021 Contacts/Locations and Study Status
5 April 15, 2021 Contacts/Locations and Study Status
6 May 13, 2021 Contacts/Locations and Study Status
7 June 9, 2021 Contacts/Locations and Study Status
8 July 6, 2021 Contacts/Locations and Study Status
9 August 3, 2021 Contacts/Locations and Study Status
10 September 9, 2021 Contacts/Locations and Study Status
11 October 6, 2021 Contacts/Locations and Study Status
12 November 3, 2021 Contacts/Locations and Study Status
13 November 29, 2021 Contacts/Locations and Study Status
14 December 16, 2021 Study Status
15 January 12, 2022 Contacts/Locations and Study Status
16 February 10, 2022 Contacts/Locations and Study Status
17 March 14, 2022 Contacts/Locations and Study Status
18 April 11, 2022 Contacts/Locations and Study Status
19 May 9, 2022 Contacts/Locations and Study Status
20 June 7, 2022 Study Status
21 August 2, 2022 Contacts/Locations and Study Status
22 August 29, 2022 Contacts/Locations and Study Status
23 October 3, 2022 Recruitment Status, Contacts/Locations, Study Status and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT04592913
Submitted Date:  October 13, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: D910GC00001
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)
Secondary IDs: 2019-001555-40 [EudraCT Number]
Open or close this module Study Status
Record Verification: September 2020
Overall Status: Not yet recruiting
Study Start: November 27, 2020
Primary Completion: February 14, 2025 [Anticipated]
Study Completion: February 14, 2025 [Anticipated]
First Submitted: August 26, 2020
First Submitted that
Met QC Criteria:
October 13, 2020
First Posted: October 19, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 13, 2020
Last Update Posted: October 19, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: AstraZeneca
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
Open or close this module Conditions
Conditions: Gastrointestinal Neoplasms
Esophagogastric Junction
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Randomized, Double-blind, Placebo-controlled study
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 900 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Event-free survival (EFS)
[ Time Frame: Up to 5 years ]

EFS is the time from date of randomization until the date of disease progression or death.
Secondary Outcome Measures:
1. To compare Arm A relative to Arm B on overall survival (OS)
[ Time Frame: Up to 5 years ]

Overall survival is length of time from randomization until the date of death due to any cause.
2. To compare Arm A relative to Arm B on pathological complete response (pCR) rate
[ Time Frame: Up to 5 years ]

pCR rate is the proportion of patients who have no residual viable tumor in the resected specimens.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: AstraZeneca Clinical Study Information Center
Telephone: 1-877-240-9479
Email: information.center@astrazeneca.com
Locations: Taiwan
Research Site
Kaohsiung, Taiwan, 807
Research Site
Taipei, Taiwan, 112
Research Site
Taoyuan City, Taiwan, 333
Open or close this module IPDSharing
Plan to Share IPD: Yes

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.

Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
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.
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
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services