A Validation Study of Relationships Among Genomic Gene Expression Profile, Prognosis and Prediction of Adjuvant Chemotherapy Benefit With Capecitabine and Oxaliplatin in Gastric Cancer Stage II and III (6th AJCC) Patients After D2 Surgery (CLASSIC)

January 11, 2018 updated by: Yonsei University

A Validation Study of Relationships Among Genomic Gene Expression Profile, Prognosis and Prediction of Adjuvant Chemotherapy Benefit With Capecitabine and Oxaliplatin in Gastric Cancer Stage II and III (6th AJCC) Patients After D2 Surgery Using a Phase 3 Randomized Clinical Trial Sample (CLASSIC)

The purpose of this study is to validate a pre-defined single-patient classifier algorithm for predicting prognosis and benefit from adjuvant chemotherapy for patients who underwent D2 gastrectomy for stage II and III gastric cancer. This algorithm classifies gastric cancer into five groups according to its molecular characteristics based on RNA expression levels. The prognosis and response from adjuvant chemotherapy will be different according to prognostic and predictive clusters respectively based on these groups, thus this algorithm can identify as patients which will have benefit from adjuvant chemotherapy or which will not. Consequently, this algorithm can be translated into clinical practice to help doctors who decide the necessity of adjuvant chemotherapy after D2 gastrectomy for patients who had diagnosed stage II and III gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to validate a pre-defined single-patient classifier algorithm for predicting prognosis and benefit from adjuvant chemotherapy for patients who underwent D2 gastrectomy for stage II and III gastric cancer. This algorithm classifies gastric cancer into five groups according to its molecular characteristics based on RNA expression levels. The prognosis and response from adjuvant chemotherapy will be different according to prognostic and predictive clusters respectively based on these groups, thus this algorithm can identify as patients which will have benefit from adjuvant chemotherapy or which will not. Consequently, this algorithm can be translated into clinical practice to help doctors who decide the necessity of adjuvant chemotherapy after D2 gastrectomy for patients who had diagnosed stage II and III gastric cancer.

The cohort for this validation study is from patients who were enrolled the CLASSIC (Capecitabine and oxaliplatin Adjuvant Study in Stomach Cancer) trial, a randomized, open-label, multicenter, parallel-group, phase 3 study which compared the effect of adjuvant capecitabine plus oxaliplatin (XELOX) after D2 gastrectomy with surgery alone strategy. This trial was conducted between June, 2006 and June, 2009. The patient were from both surgery alone arm and surgery plus adjuvant XELOX arm, and have tumor blocks available for RNA extraction.

Study Type

Observational

Enrollment (Actual)

640

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Surgery, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

approximately 640 FFPE sample blocks from patients among 1035 enrolled in the CLASSIC trial (satisfied with below criteria)

Description

Inclusion Criteria:

  • aged 18 years or older
  • histologically confirmed, American Joint Committee on Cancer/Union Internationale Contre le Cancer (6th edition) 2 stage II (T2N1, T1N2, T3N0), IIIA (T3N1, T2N2, T4N0), or IIIB (T3N2) gastric adenocarcinoma with no evidence of metastatic disease
  • previous D2 surgery with achieved R0 resection
  • Karnofsky performance status of >70%
  • adequate renal function (creatinine clearance >50 mL/min or serum creatinine ≤1·5 times the upper limit of normal), hepatic function (total bilirubin ≤1·5 times the upper limit of normal, aspartate or alanine aminotransferase ≤2·5 times the upper limit of normal), and hematological function (absolute neutrophil count ≥1·5 × 109/L or platelet count ≥100 × 109/L)
  • adequate hepatic function
  • formalin-fixed paraffin-embedded (FFPE) tumor blocks, pathologic reports, and clinical information were all available.

Exclusion Criteria:

  • chemotherapy, immunotherapy, or radiotherapy for GC prior to surgery
  • no available FFPE tumor blocks
  • insufficient RNA quality to be analyzed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CLASSIC cohort
Patients with stage II-III GC who underwent D2 resection were randomized (1:1) after surgery to receive adjuvant capecitabine and oxaliplatin (eight three-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or observation alone. Assessment whether patients were disease free were done by abdominal CT or MRI and chest radiograph at regular intervals as planned by protocol.
Genetic: nProfiler I Stomach Cancer Assay Kit
qPCR by nProfiler I Stomach Cancer Assay Kit
Other Names:
  • nProfiler I Stomach Cancer Assay Kit (Novomics Co., Korea)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival(OS)
Time Frame: 5 years
the time from randomization to the date of death from any cause.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 13, 2016

Primary Completion (ACTUAL)

July 12, 2017

Study Completion (ACTUAL)

July 12, 2017

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 11, 2018

First Posted (ACTUAL)

January 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2016-0433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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