Stage IV or Unresectable Gastric CancerConGC-IINCT03366961
Conversion Surgery in Stage IV or Unresectable Gastric Cancer
A study testing Conversion surgery in people with Stage IV or Unresectable Gastric Cancer, run by Cho Hyun Park at 1 site in South Korea.
Trial summary
This study aims to identify the safety and the survival benefit of the conversion surgery in stage IV or unresectable gastric cancer. The study designed single-arm phase II trial. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stage IV or Unresectable Gastric Cancer
- What is being tested?
- Conversion surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2017to 31 Dec 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastric adenocarcinoma
- Stage IV or unresectable gastric cancer was diagnosed by pre-operative evaluation including endoscopy, endoscopic ultrasound, Computed tomography (CT), Positron emission tomography-computed tomography (PET CT), or staging laparoscopy
- Partial or complete response to chemotherapy
- Eastern Cooperative Oncology Group (ECOG) score <3
- Who agreed to enroll the study
Who cannot join
- Synchronous or metachronous malignancy
- remnant gastric cancer
- BMI less than 18.5
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Multi-national Multi-institutional Phase 2 Trial for Conversion Surgery in Stage IV or Unresectable Gastric Cancer
This study aims to identify the safety and the survival benefit of the conversion surgery in stage IV or unresectable gastric cancer. The study designed single-arm phase II trial. All the patients would undergo curative-intent radical gastrectomy after palliative chemotherapy if the tumor responded to the chemotherapy. Primary endpoint was three-year overall survival. Secondary endpoints included short-term postoperative outcomes within 30 days, three-year relapse free survival, and success rate of conversion surgery (rate of R0 resection).
Read the detailed description
The survival rate of patients with stage IV gastric cancer (GC) is very low. Recently, several retrospective studies about conversion surgery have been introduced. The results of the studies showed around 30~40% of three-year survival rate in conversion surgery group. Eight institutions in Catholic University of Korea analyzed 419 stage IV GC patients, and they had divided into four groups: chemotherapy only, chemotherapy followed by gastrectomy, gastrectomy followed by chemotherapy, and best supportive care group. The group of gastrectomy followed by chemotherapy, which is similar with conversion surgery, showed 40% of three-year survival rate. However, the study included only small number of patients who were in conversion surgery group, and had several biases. Thus, we planned multi-national, multi-center phase II trial for conversion surgery in stage IV or unresectable GC.
- Conditions
- Stage IV or Unresectable Gastric Cancer
- Being tested
- Conversion surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversion surgeryProcedure or surgery
Palliative chemotherapy followed by radical gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Conversion surgery | Other | Palliative chemotherapy followed by radical gastrectomy Receives: Procedure: Conversion surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival
3-year overall survival after conversion surgery
Measured: 3 years after the surgery
Secondary outcomes (4)
Complication
Short-term complication rate after conversion surgery
Measured: 30 days after the surgery
3-year disease free survival
3-year disease free survival after conversion surgery
Measured: 3 years after the surgery
Success rate of conversion surgery
Rate of R0 resection
Measured: 30 days after the surgery
Response rate of chemotherapy
Response rate of chemotherapy
Measured: Operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Dec 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV or Unresectable Gastric CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cho Hyun Park
- Sponsor type
- University, hospital or other
- Collaborators
- The Catholic University of Korea, Peking University
- Responsible party
- Sponsor-investigator, Cho Hyun Park, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366961
- Sponsor's protocol ID
- ConGC-II
- Acronym
- ConGC-II
- Status last verified
- Sep 2019
- First submitted
- 4 Dec 2017
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multi-national Multi-institutional Phase 2 Trial for Conversion Surgery in Stage IV or Unresectable Gastric Cancer
- ClinicalTrials.gov ID
- NCT03366961
- Acronym / sponsor ID
- ConGC-II / ConGC-II
- Conditions
- Stage IV or Unresectable Gastric Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cho Hyun ParkUniversity, hospital or other
- Collaborators
- The Catholic University of Korea, Peking University
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Dec 2017 (actual)
- 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 study aims to identify the safety and the survival benefit of the conversion surgery in stage IV or unresectable gastric cancer. The study designed single-arm phase II trial. All the patients would undergo curative-intent radical gastrectomy after palliative chemotherapy if the tumor responded to the chemotherapy. Primary endpoint was three-year overall survival. Secondary endpoints included short-term postoperative outcomes within 30 days, three-year relapse free survival, and success rate of conversion surgery (rate of R0 resection).
Detailed description
The survival rate of patients with stage IV gastric cancer (GC) is very low. Recently, several retrospective studies about conversion surgery have been introduced. The results of the studies showed around 30~40% of three-year survival rate in conversion surgery group. Eight institutions in Catholic University of Korea analyzed 419 stage IV GC patients, and they had divided into four groups: chemotherapy only, chemotherapy followed by gastrectomy, gastrectomy followed by chemotherapy, and best supportive care group. The group of gastrectomy followed by chemotherapy, which is similar with conversion surgery, showed 40% of three-year survival rate. However, the study included only small number of patients who were in conversion surgery group, and had several biases. Thus, we planned multi-national, multi-center phase II trial for conversion surgery in stage IV or unresectable GC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conversion surgery | Other | Procedure: Conversion surgeryPalliative chemotherapy followed by radical gastrectomy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gastric adenocarcinoma
- Stage IV or unresectable gastric cancer was diagnosed by pre-operative evaluation including endoscopy, endoscopic ultrasound, Computed tomography (CT), Positron emission tomography-computed tomography (PET CT), or staging laparoscopy
- Partial or complete response to chemotherapy
- Eastern Cooperative Oncology Group (ECOG) score <3
- Who agreed to enroll the study
Key exclusion criteria (4 listed)
- Synchronous or metachronous malignancy
- remnant gastric cancer
- BMI less than 18.5
- Pregnancy
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 |
|---|---|---|
| Conversion surgeryPalliative chemotherapy followed by radical gastrectomy | Procedure or surgery | Conversion surgery |
Primary outcome
3-year overall survival
Time frame: 3 years after the surgery
3-year overall survival after conversion surgery
4 secondary outcomes
Complication
Time frame: 30 days after the surgery
3-year disease free survival
Time frame: 3 years after the surgery
Success rate of conversion surgery
Time frame: 30 days after the surgery
Response rate of chemotherapy
Time frame: Operation day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conversion surgery in people with Stage IV or Unresectable Gastric Cancer, run by Cho Hyun Park at 1 site 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 4 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: withdrawn, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
3-year overall survival (time frame: 3 years after the surgery). 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 19 Sep 2019.