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)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04592913Tipo: INTERVENTIONALInicio: 17 de nov de 2020Fin estimado: 27 de sept de 2027

Traducción no disponible, mostrando original

Resumen

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).

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 200 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Durvalumab

Human monoclonal antibody

drug

FLOT chemotherapy

A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Ciudad Autonoma Buenos Aires, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Rosario, Argentina

Research Site

Rosario, Argentina

Patrocinadores

PrincipalAstraZeneca

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