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Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer

NCT04592913

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Gastrointestinal Neoplasms, Esophagogastric Junction

Interventions: Durvalumab, FLOT chemotherapy

Countries: United States, Argentina, Belgium, Brazil, Canada, Chile, Denmark, France

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 200 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (156)
  • Duarte, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Sylmar, California, United States
  • St. Petersburg, Florida, United States
  • Tallahassee, Florida, United States
  • West Palm Beach, Florida, United States
  • Fort Wayne, Indiana, United States
  • Louisville, Kentucky, United States
  • Boston, Massachusetts, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Lancaster, Texas, United States
  • Seattle, Washington, United States
  • Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Rosario, Argentina
  • Rosario, Argentina
  • Charleroi, Belgium
  • Edegem, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Roeselare, Belgium
  • Barretos, Brazil
  • Natal, Brazil
  • Porto Alegre, Brazil
  • + 126 more on CT.gov