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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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