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

Gastric Cancer Clinical Trial

— NJBMR  

Official title:

Retrospective Validation for Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy With S-1

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01905969
• Other study ID #: MIAST-NJBMR-12
• Status: Active, not recruiting
• Phase: N/A
• First received: July 19, 2013
• Last updated: March 24, 2015
• Start date: October 2012
• Est. completion date: March 2016

Study information

• Verified date: March 2015
• Source: Iwate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 2016
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Japan	Iwate Medical University School of Medicine	Morioka	Iwate

Sponsors (1)

Lead Sponsor	Collaborator
Iwate Medical University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Ishida K, Nishizuka SS, Chiba T, Ikeda M, Kume K, Endo F, Katagiri H, Matsuo T, Noda H, Iwaya T, Yamada N, Fujiwara H, Takahashi M, Itabashi T, Uesugi N, Maesawa C, Tamura G, Sugai T, Otsuka K, Koeda K, Wakabayashi G. Molecular marker identification for relapse prediction in 5-FU-based adjuvant chemotherapy in gastric and colorectal cancers. PLoS One. 2012;7(8):e43236. doi: 10.1371/journal.pone.0043236. Epub 2012 Aug 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse free survival		3 years	No