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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210307

Registered date:13/09/2021

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)

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedGastrointestinal Neoplasms, Esophagogastric Junction
Date of first enrollment31/01/2021
Target sample size86
Countries of recruitmentArgentina,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,Germany,Japan,Denmark,Japan,Spain,Japan,France,Japan,United Kingdom,Japan,Hungary,Japan,South Korea,Japan,Netherlands,Japan,Peru,Japan,Poland,Japan,Russia,Japan,Turkey,Japan,Taiwan,Japan,US,Japan
Study typeInterventional
Intervention(s)Arm A Durvalumab (Human monoclonal antibody) FLOT chemotherapy(A combination treatment made up of flurouroacil, isovorin, oxaliplatin, docetaxel) Arm B FLOT chemotherapy (A combination treatment made up of flurouroacil, isovorin, oxaliplatin, docetaxel)

Outcome(s)

Primary OutcomeEvent-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

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include 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.
Exclude 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.

Related Information

Contact

Public contact
Name Kazushige Hibi
Address 3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-0011
Telephone +81-6-4802-3533
E-mail RD-clinical-information-Japan@astrazeneca.com
Affiliation Astrazeneka K.K
Scientific contact
Name Kazushige Hibi
Address 3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-0011
Telephone +81-6-4802-3533
E-mail RD-clinical-information-Japan@astrazeneca.com
Affiliation Astrazeneka K.K