The Screening Protocol for The VIKTORY Trial

The Screening Protocol for The VIKTORY Trial- Targeted Agent eValuation in gastrIc Cancer basKeT KORea studY: SMC-AZ GC Basket Trial Screening Protocol

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.

Study Overview

• Status: Completed
• Conditions: Stomach Neoplasms
• Intervention / Treatment: Other: Molecular profiling

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
• Enrollment (Actual): 651
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm; molecular profiling, patient derived cells	Other: Molecular profiling; molecular profiling, patient derived cells, fresh or FFPE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
molecular screening ( biopsy of their tumor and will be analyzed using cancer panel/nanostring CNV and immunohistochemistry)	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	OS (biomarker negative vs biomarker postivie metastatic GC patients)	1years
PFS	PFS (biomarker negative vs biomarker postivie metastatic GC patients)	1years
OS/PFS	OS/PFS (EBV negative vs positive metastatic GC patients)	1years

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Jeeyun Lee, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2014
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: October 16, 2014
• First Submitted That Met QC Criteria: November 21, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2014-04-119-009