The Screening Protocol for The VIKTORY Trial

Stomach Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299648
• Other study ID #: 2014-04-119-009
• Status: Completed
• Phase: N/A
• Start date: July 25, 2014
• Est. completion date: May 17, 2022

Study information

• Verified date: June 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 651
• Est. completion date: May 17, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Other:
• Molecular profiling
molecular profiling, patient derived cells, fresh or FFPE

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	OS	OS (biomarker negative vs biomarker postivie metastatic GC patients)	1years
Secondary	PFS	PFS (biomarker negative vs biomarker postivie metastatic GC patients)	1years
Secondary	OS/PFS	OS/PFS (EBV negative vs positive metastatic GC patients)	1years