This study is in progress, not accepting new patients

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

a study on Gastrointestinal Cancer Esophagogastric Junction Gastroesophageal Junction Cancer Digestive System Tumor

Summary

Eligibility
for people ages 18-200 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Zev Wainberg (ucla)

Description

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).

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)

Details

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.

Keywords

Gastrointestinal Neoplasms, Esophagogastric Junction, Digestive System Neoplasms, Durvalumab, FLOT chemotherapy

Eligibility

You can join if…

Open to people ages 18-200

  • 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.

You CAN'T join if...

  • 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

  • Research Site
    Los Angeles California 90095 United States
  • Research Site
    Los Angeles California 90027 United States
  • Research Site
    Sylmar California 91342 United States
  • Research Site
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Zev Wainberg (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 152 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT04592913
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 958 people participating
Last Updated