Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy (NJBMR)

Iwate Medical University

Status: Unknown

Conditions: Gastric Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01905969

MIAST-NJBMR-12

Details and patient eligibility

About

Adjuvant chemotherapy followed by curative gastrectomy for Stage II/III gastric cancer has improved disease free time and survival. However, there are still considerable number of patients experience relapse even after adjuvant chemotherapy. In an attempt to select patients who really benefit the postoperative adjuvant chemotherapy, we have identified potential biomarkers (NF-kappaB/JNK) from cell line panel screening followed by immunohistochemical validation. In the present study, we further validate the significance of the biomarkers in a larger set of clinical samples to see if chemotherapeutic response can be determined immediately after surgery.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed gastric cancer.
• Operated before November 2009.
• Stage Ib/II(except for T1, T3N0)/III.
• Received postoperative (R0) adjuvant chemotherapy (S-1).
• Not received postoperative (R0) adjuvant chemotherapy (surgery alone).
• Signed informed consent to provide paraffin embedded tissue of removed specimens.

Exclusion criteria

• With advanced neoplastic lesions other than gastric cancer.
• Paraffin embedded tissue is not available.
• Unknown S-1 treatment condition.

Trial design

500 participants in 2 patient groups

Biomarker positive

Description:

NF-kB(+)/JNK(-) in curatively removed specimens

Biomarker negative

Description:

NF-kB(-)/JNK(+) in curatively removed specimens