Stomach NeoplasmsNCT02299648
The Screening Protocol for The VIKTORY Trial
A study testing Molecular profiling in people with Stomach Neoplasms, run by Samsung Medical Center at 2 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Molecular profiling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 651 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 25 Jul 2014to 17 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Prior history of taxane treatment as palliative chemotherapy
- Uncontrolled systemic illness and infection
- Pregnant or nursing women
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Samsung Medical center
Seoul, 135-710
Samsung Medical Center
Seoul
About this study
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
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.
Read the 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
- 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.
- Secondary Objective
Planned subgroup analyses:
- OS (biomarker negative vs biomarker postivie metastatic GC patients)
- PFS (biomarker negative vs biomarker postivie metastatic GC patients)
- OS/PFS (EBV negative vs positive metastatic GC patients)
- Conditions
- Stomach Neoplasms
- Being tested
- Molecular profiling
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular profilingOther
molecular profiling, patient derived cells, fresh or FFPE
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | molecular profiling, patient derived cells Receives: Other: Molecular profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
OS (biomarker negative vs biomarker postivie metastatic GC patients)
Measured: 1years
PFS
PFS (biomarker negative vs biomarker postivie metastatic GC patients)
Measured: 1years
OS/PFS
OS/PFS (EBV negative vs positive metastatic GC patients)
Measured: 1years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study start25 Jul 2014
- Primary completion30 Dec 2021
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
- Investigators
- Jeeyun Lee, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299648
- Sponsor's protocol ID
- 2014-04-119-009
- Status last verified
- Jun 2022
- First submitted
- 16 Oct 2014
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02299648
- Acronym / sponsor ID
- 2014-04-119-009
- Conditions
- Stomach Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 25 Jul 2014 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- Secondary Objective
Planned subgroup analyses:
- OS (biomarker negative vs biomarker postivie metastatic GC patients)
- PFS (biomarker negative vs biomarker postivie metastatic GC patients)
- OS/PFS (EBV negative vs positive metastatic GC patients)
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Other: Molecular profilingmolecular profiling, patient derived cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Prior history of taxane treatment as palliative chemotherapy
- Uncontrolled systemic illness and infection
- Pregnant or nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular profilingmolecular profiling, patient derived cells, fresh or FFPE | Other | Single arm |
Primary outcome
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.
3 secondary outcomes
OS
Time frame: 1years
PFS
Time frame: 1years
OS/PFS
Time frame: 1years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
Related trials for Stomach Neoplasms
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Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Recruiting
Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial
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Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms
Active, not recruiting
Telehealth for the Self-Management of Dietary Quality of Life in Patients After Stomach Cancer Surgery
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Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer
Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeeyun Lee, MD principal investigator
Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular profiling in people with Stomach Neoplasms, run by Samsung Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.