Status:
COMPLETED
The Screening Protocol for The VIKTORY Trial
Lead Sponsor:
Samsung Medical Center
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
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. Howev...
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 immunohisto...
Eligibility Criteria
Inclusion
- 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
- Prior history of taxane treatment as palliative chemotherapy
- Uncontrolled systemic illness and infection
- Pregnant or nursing women
Key Trial Info
Start Date :
July 25 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2022
Estimated Enrollment :
651 Patients enrolled
Trial Details
Trial ID
NCT02299648
Start Date
July 25 2014
End Date
May 17 2022
Last Update
June 15 2022
Active Locations (2)
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1
Samsung Medical center
Seoul, South Korea, 135-710
2
Samsung Medical Center
Seoul, South Korea