Gastric CancerTOCCATANCT06103435
Multivisceral Resections for Locally Advanced Gastric Cancer
An observational study of Gastric Cancer, run by Jagiellonian University at 1 site in Poland.
Trial summary
The goal of this observational study is to assess whether the postoperative course and survival of patients subject to multivisceral resections for locally advanced gastric cancer (cT4b) were affected by the extent of surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Extent od surgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 1,476 participants
- Where
- 1 sitePoland
- Study dates
- Jan 1996to Dec 2020
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with resectable gastric cancer treated between January 1996 and December 2020 in the First Department of Surgery, Jagiellonian University Medical College
Who may be able to join
- gastric adenocarcinoma
- intraoperatively suspected infiltration of surrounding organs (stage cT4bN0-3bM0)
- partial or total gastrectomy
Who cannot join
- distant metastases (M1)
- gastrectomy combined with resection of organs other than spleen, pancreas, or colon
Trial locations and contacts
1 site in 1 country.
Poland1 site
First Department of Surgery, Jagiellonian University Medical College
Krakow, Małopolska, 30-688
About this study
The goal of this observational study is to assess whether the postoperative course and survival of patients subject to multivisceral resections for locally advanced gastric cancer (cT4b) were affected by the extent of surgery. An electronic database of 1476 patients with non-metastatic gastric cancer treated between January 1996 and December 2020 will be reviewed. The main questions it aims to answer are:
- Does splenectomy, distal pancreatectomy or partial colectomy affect postoperative complications
- What factors affect prognosis of patients with locally advanced gastric cancer
- Conditions
- Gastric Cancer
- Being tested
- Extent od surgical resection
- Keywords
- gastric cancer, locally advanced cancers, multivisceral resections, splenectomy, pancreatectomy, colectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extent od surgical resectionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Type and severity of complications graded by Clavien-Dindo scoring system (from 0 to 5, higher scores mean worse outcome)
Measured: up to 90 days
Survival
Overall survival
Measured: Overall survival from surgery to death or last follow up, whichever came first, assessed up to 60 months
Secondary outcomes (3)
Rate of reoperations
Reoperations
Measured: up to 90 days
Length of postoperative hospital stay
Hospital stay
Measured: Up to 6 months
Rate of readmissions
Readmission
Measured: One year from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study startJan 1996
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marek Sierzega, Jagiellonian University
- Investigators
- Marek Sierżęga, MD, PhD, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103435
- Sponsor's protocol ID
- GC_MVR
- Acronym
- TOCCATA
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 26 Oct 2023
- 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 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multivisceral Resections for Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06103435
- Acronym / sponsor ID
- TOCCATA / GC_MVR
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, locally advanced cancers, multivisceral resections, splenectomy, pancreatectomy, colectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,476 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jan 1996 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 26 Oct 2023 (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.
The goal of this observational study is to assess whether the postoperative course and survival of patients subject to multivisceral resections for locally advanced gastric cancer (cT4b) were affected by the extent of surgery. An electronic database of 1476 patients with non-metastatic gastric cancer treated between January 1996 and December 2020 will be reviewed. The main questions it aims to answer are:
- Does splenectomy, distal pancreatectomy or partial colectomy affect postoperative complications
- What factors affect prognosis of patients with locally advanced gastric cancer
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with resectable gastric cancer treated between January 1996 and December 2020 in the First Department of Surgery, Jagiellonian University Medical College
Key inclusion criteria (3 listed)
- gastric adenocarcinoma
- intraoperatively suspected infiltration of surrounding organs (stage cT4bN0-3bM0)
- partial or total gastrectomy
Key exclusion criteria (2 listed)
- distant metastases (M1)
- gastrectomy combined with resection of organs other than spleen, pancreas, or colon
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 |
|---|---|---|
| Extent od surgical resection | Procedure or surgery | – |
Primary outcome
Complications
Time frame: up to 90 days
Type and severity of complications graded by Clavien-Dindo scoring system (from 0 to 5, higher scores mean worse outcome)
Survival
Time frame: Overall survival from surgery to death or last follow up, whichever came first, assessed up to 60 months
Overall survival
3 secondary outcomes
Rate of reoperations
Time frame: up to 90 days
Length of postoperative hospital stay
Time frame: Up to 6 months
Rate of readmissions
Time frame: One year from surgery
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 26 Oct 2023.
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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.
Marek Sierżęga, MD, PhD principal investigator
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Jagiellonian University at 1 site in Poland.
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 3 inclusion and 2 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 26 Oct 2023. 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 Poland. 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?
Complications (time frame: up to 90 days). The study lists 2 primary outcomes in all. 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 26 Oct 2023.