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

Status
Active
Cancer Type
Stomach/ Gastric Cancer
Trial Phase
Phase III
Eligibility
18 - 200 Years, Male and Female
Study Type
Treatment
NCT ID
NCT04592913
Protocol IDs
D910GC00001 (primary)
NCI-2021-01109
2019-001555-40
Study Sponsor
AstraZeneca Pharmaceuticals LP

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).

Objectives

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.

Eligibility

  1. Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
  2. Patients must undergo radical surgery.
  3. No prior anti-cancer therapy for the current malignancy.
  4. World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment.
  5. Adequate organ and marrow function.
  6. Availability of tumor sample prior to study entry.
  7. Must have a life expectancy of at least 24 weeks.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.