UMIN ID: UMIN000056810
Registered date:27/01/2025
An Observational Study Evaluating Clinicopathological Features of Patients with FGFR2b Positive Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma(WJOG18524GPS)
Basic Information
Recruitment status | Recruiting |
---|---|
Health condition(s) or Problem(s) studied | FGFR2b positive unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma |
Date of first enrollment | 2025/03/03 |
Target sample size | 1000 |
Countries of recruitment | Japan |
Study type | Observational |
Intervention(s) |
Outcome(s)
Primary Outcome | the proportion of FGFR2b-positive cases of unresectable advanced or recurrent gastric cancer |
---|---|
Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 18years-old |
---|---|
Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1) Active double cancer requiring active treatment such as chemotherapy or surgery (synchronous or metachronous double cancer with a disease-free period of 3 years). Exceptions include cases where the risk of metastasis or death is negligible and cure is expected with local treatment (e.g., appropriately treated cervical intraepithelial neoplasia, basal cell carcinoma, cutaneous squamous cell carcinoma, localized prostate cancer treated with curative intent, ductal carcinoma treated in situ with curative intent). 2) History of taxane-based agent administration (including neoadjuvant or adjuvant chemotherapy). 3) History of FGF-FGFR pathway or VEGF-VEGFR pathway inhibitor administration. 4) Cases deemed inappropriate for enrollment by the attending physician. |
Related Information
Primary Sponsor | West Japan Oncology Group |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | Amgen K.K. |
Secondary ID(s) |
Contact
public contact | |
Name | Naoki Ishizuka |
Address | Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN Japan 556-0016 |
Telephone | 06-6633-7400 |
datacenter@wjog.jp | |
Affiliation | West Japan Oncology Group WJOG datacenter |
scientific contact | |
Name | Kenro Hirata |
Address | 5 Shinanomachi, Shinjuku-ku, Tokyo Japan |
Telephone | 03-5363-3288 |
kenro@keio.jp | |
Affiliation | Keio University School of Medicine Cancer center |