Overview

This trial is active, not recruiting.

Condition gastric cancer
Sponsor Iwate Medical University
Start date October 2012
End date March 2014
Trial size 500 participants
Trial identifier NCT01905969, MIAST-NJBMR-12

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
NF-kB(+)/JNK(-) in curatively removed specimens
NF-kB(-)/JNK(+) in curatively removed specimens

Primary Outcomes

Measure
Relapse free survival
time frame: 3 years

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Retrospective Validation for Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy With S-1
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Iwate Medical University.