The Screening Protocol for The VIKTORY Trial

NCT02299648 | Completed DMC

• 1 other identifier: 2014-04-119-009
• Study Type: interventional
• Target: 651
• Locations: 1 country
• Sites: 2

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.

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• OS

  1years

• PFS

  1years

• OS/PFS

  1years

Study Arms (1)

Single arm

OTHER

molecular profiling, patient derived cells

Other: Molecular profiling

Interventions

Molecular profiling OTHER

molecular profiling, patient derived cells, fresh or FFPE

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (2)

Samsung Medical center

Seoul, 135-710, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jeeyun Lee, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: November 24, 2014
• Study Start: July 25, 2014
• Primary Completion: December 30, 2021
• Study Completion: May 17, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

KR (2)