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 |
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Health condition(s) or Problem(s) studied | Gastrointestinal Neoplasms, Esophagogastric Junction |
Date of first enrollment | 31/01/2021 |
Target sample size | 86 |
Countries of recruitment | Argentina,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 type | Interventional |
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 Outcome | Event-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. |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
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
Primary Sponsor | Hibi Kazushige |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04592913 |
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 |
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 |
RD-clinical-information-Japan@astrazeneca.com | |
Affiliation | Astrazeneka K.K |