Cancer of StomachNCT05747482
Omentectomy vs Omental Preservation in Resectable Cancer
A study testing Surgery procedure in people with Cancer of Stomach, run by Corporacion Parc Tauli.
Trial summary
European clinical guidelines do not establish a clear recommendation neither for nor against omentectomy of this segment, the American clinical guidelines recommend omentectomy in view of its potential long-term oncological benefit, and Japanese clinical guidelines only recommend 2nd segment omentectomy in locally… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Stomach
- What is being tested?
- Surgery procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 569 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Older than 18 years old
- Resectable gastric cancer
- Gastric cancer T3-4 N+/- M0
Who cannot join
- M1
- Non surgical patients for medical status
- Non resectable gastric cancer during surgery
- Endoscopic resectable gastric cancer
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Non-inferiority Randomized Clinical Trial Comparing Omenectomy and Omental Preservation in Resectable Gastric Cancer
European clinical guidelines do not establish a clear recommendation neither for nor against omentectomy of this segment, the American clinical guidelines recommend omentectomy in view of its potential long-term oncological benefit, and Japanese clinical guidelines only recommend 2nd segment omentectomy in locally advanced gastric cancers (stage T3-T4) recommending omental preservation in early gastric cancers (stage T1-T2).
Faced with this lack of consensus, we propose a randomized, prospective and multicentric study in patients with resectable gastric cancer in stage T3-4 N+/- M0. Patients will be randomized into two groups, one where omentectomy of the 2nd omental portion will be performed and another where omental preservation will be performed.
The aim of our study is to analyze the disease-free interval and survival between both groups, also comparing postoperative complications and mortality.
- Conditions
- Cancer of Stomach
- Being tested
- Surgery procedure
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery procedureOther
Also called Omentectomy, Omental preservation
Omentectomy vs omental preservations during gastric surgery
| Study group | Role | What they receive |
|---|---|---|
| Omentectomy | Other | Omentectomy during cancer gastric surgery Receives: Other: Surgery procedure |
| Omental preservation | Other | Preserval omentation during cancer gastric surgery Receives: Other: Surgery procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free interval
time between surgery and recurrence. Units of measure: months
Measured: 5 years
Secondary outcomes (4)
global survival
survival between surgery and last follow-up date. Units of measure: percentage
Measured: 5 years
survival at 5 years
survival between surgery and 5 years. Units of measure: percentage
Measured: 5 years
complications - CCI
type of complications and CCI number. Units of measure: enter number between 1 and 100
Measured: 30 days after surgery
postoperatory mortality
mortality after surgery. Units of measure: percentage
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of StomachStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 569 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Montmany-Vioque, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747482
- Sponsor's protocol ID
- SMontmany2022
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Randomized Clinical Trial Comparing Omenectomy and Omental Preservation in Resectable Gastric Cancer
- ClinicalTrials.gov ID
- NCT05747482
- Acronym / sponsor ID
- SMontmany2022
- Conditions
- Cancer of Stomach
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 569 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 28 Feb 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.
European clinical guidelines do not establish a clear recommendation neither for nor against omentectomy of this segment, the American clinical guidelines recommend omentectomy in view of its potential long-term oncological benefit, and Japanese clinical guidelines only recommend 2nd segment omentectomy in locally advanced gastric cancers (stage T3-T4) recommending omental preservation in early gastric cancers (stage T1-T2).
Faced with this lack of consensus, we propose a randomized, prospective and multicentric study in patients with resectable gastric cancer in stage T3-4 N+/- M0. Patients will be randomized into two groups, one where omentectomy of the 2nd omental portion will be performed and another where omental preservation will be performed.
The aim of our study is to analyze the disease-free interval and survival between both groups, also comparing postoperative complications and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omentectomy | Other | Other: Surgery procedureOmentectomy during cancer gastric surgery |
| Omental preservation | Other | Other: Surgery procedurePreserval omentation during cancer gastric surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years old
- Resectable gastric cancer
- Gastric cancer T3-4 N+/- M0
Key exclusion criteria (4 listed)
- M1
- Non surgical patients for medical status
- Non resectable gastric cancer during surgery
- Endoscopic resectable gastric cancer
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 |
|---|---|---|
| Surgery procedureAlso: Omentectomy, Omental preservationOmentectomy vs omental preservations during gastric surgery | Other | Omental preservation, Omentectomy |
Primary outcome
disease free interval
Time frame: 5 years
time between surgery and recurrence. Units of measure: months
4 secondary outcomes
global survival
Time frame: 5 years
survival at 5 years
Time frame: 5 years
complications - CCI
Time frame: 30 days after surgery
postoperatory mortality
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery procedure in people with Cancer of Stomach, run by Corporacion Parc Tauli.
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 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: opening soon, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Montmany, PhD (937231010 ext. 21490, smontmany@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free interval (time frame: 5 years). 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 28 Feb 2023.