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The Screening Protocol for The VIKTORY Trial

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ClinicalTrials.gov Identifier: NCT02299648
Recruitment Status : Recruiting
First Posted : November 24, 2014
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center

Brief Summary:
This protocol is a screening protocol only. No drug intervention study will be included in this protocol. However, based on the molecular profiling, patients may be eligible for targeted agents. However, the molecular profiling doesn't guarantee the enrollment onto the clinical trial. Currently, the available drugs are AKT inhibitor, MEK inhibitor, Wee1 inhibitor, MET inhibitor. ATR inhibitor and other agents may be available in the context of clinical trials depending on the availability.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Other: Molecular profiling Not Applicable

Detailed Description:

To screen metastatic GC patients who failed or progressed on first-line chemotherapy. Patients will undergo biopsy of their tumor and will be analyzed using cancer panel/nanostring CNV and immunohistochemistry. This protocol is a screening protocol and informed consent form will be obtained again according to the biomarker profiled on this protocol if eligible. Informed consent will be obtained from patients with gastric adenocarcinoma and analysis of fresh tissue or archival FFPE at Samsung Medical Center will be performed. Patients who have prior to or completed or during the first-line chemotherapy (fluoropyramidine/platinum-based) will be eligible for screening.

After the analysis, pathologic and molecular biologic verification process about validity of the result will proceed. The biopsies will be performed before or after or during first-line treatment for molecular analysis. The patients who are screened through this protocol will undergo baseline biopsy before or after or during first-line therapy.

Study Objectives

  1. Primary Objective: To screen metastatic GC patients who failed or progressed on first-line chemotherapy. Patients will undergo biopsy of their tumor and will be analyzed using cancer panel/nanostring CNV and immunohistochemistry.
  2. Secondary Objective

Planned subgroup analyses:

  1. OS (biomarker negative vs biomarker postivie metastatic GC patients)
  2. PFS (biomarker negative vs biomarker postivie metastatic GC patients)
  3. OS/PFS (EBV negative vs positive metastatic GC patients)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Screening Protocol for The VIKTORY Trial- Targeted Agent eValuation in gastrIc Cancer basKeT KORea studY: SMC-AZ GC Basket Trial Screening Protocol
Actual Study Start Date : July 25, 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Single arm
molecular profiling, patient derived cells
Other: Molecular profiling
molecular profiling, patient derived cells, fresh or FFPE




Primary Outcome Measures :
  1. molecular screening ( biopsy of their tumor and will be analyzed using cancer panel/nanostring CNV and immunohistochemistry) [ Time Frame: from data of start of targeted tretment oriented by molecular screening until the date of first progression or date of death form any cause, whichever came first, assessed up to 1 year ]
    To screen metastatic GC patients who failed or progressed on first-line chemotherapy. Patients will undergo biopsy of their tumor and will be analyzed using cancer panel/nanostring CNV and immunohistochemistry.


Secondary Outcome Measures :
  1. OS [ Time Frame: 1years ]
    OS (biomarker negative vs biomarker postivie metastatic GC patients)

  2. PFS [ Time Frame: 1years ]
    PFS (biomarker negative vs biomarker postivie metastatic GC patients)

  3. OS/PFS [ Time Frame: 1years ]
    OS/PFS (EBV negative vs positive metastatic GC patients)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed Metastatic or recurrent esophageal, gastroesophageal or gastric adenocarcinoma
  • Progressed and/or completed one platinum/fluoropyrimidine-based cytotoxic chemotherapy regimen (any adjuvant treatment will not be considered as one palliative regimen): patients who have prior to or completed or during first-line chemotherapy will be eligible for screening.
  • Tissue specimens: surgical specimens, endoscopic biopsies, colono/sigmoidoscopic biopsies, liver biopsies, lymph node biopsies, malignant cells isolated from ascites/pleural effusion/pericardial effusion/other malignancy related body fluids with sufficient number of malignant cells for DNA/RNA extractions will be allowed.
  • Age ≥ 20 years 5) ECOG performance status 0-1 6) Written informed consent - Life expectancy ≥ 3 months
  • Patients with available archival tissues for molecular analysis or patients who agreed with biopsy for molecular analysis (however, fresh frozen tissue will be considered first)

Exclusion Criteria:

  • Prior history of taxane treatment as palliative chemotherapy
  • Uncontrolled systemic illness and infection
  • Pregnant or nursing women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299648


Contacts
Contact: Hyeon Ju Lee, RN 822-3410-7395 hj0318.lee@samsung.com

Locations
Korea, Republic of
Samsung Medical center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Yoonjeong Ahn    82-2-2148-7395    younjeong.ahn@samsung.com   
Principal Investigator: Jeeyun Lee, MD,PhD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jeeyun Lee, M.D., Ph.D.    82-2-3410-3459    jyun.lee@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Jeeyun Lee, MD Samsung Medical Center

Responsible Party: Jeeyun Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02299648     History of Changes
Other Study ID Numbers: 2014-04-119-009
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases