Gastric CancerNCT06243757
A Study of Minimally Invasive Proximal Gastrectomy Versus Minimally Invasive Total Gastrectomy for Gastric and Gastroesophageal Junction Cancers
An observational study of Gastric Cancer and GastroEsophageal Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
Participants will a diagnosis of gastroesophageal junction (GEJ) adenocarcinoma and will have either a minimally invasive proximal gastrectomy (MIPG) or a minimally invasive total gastrectomy (MITG) as part of their routine care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, GastroEsophageal Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- MDASI-GI
- How many people
- 4 participants
- Where
- 8 sitesUnited States
- Study dates
- 8 Jan 2024to 8 Jan 2036
- Phase
- Observational
- 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
Study population: The initial contact with the potential participants will be conducted either by the treatment team, investigator or the research staff working in consultation with the treatment team. Participants will be screened in gastric and mixed tumor surgery clinics on the 5th floor of the MSKCC 53rd Street outpatient clinic building. The investigator/research staff will review portions of the medical record to determine if they are eligible. Participants who are eligible will be approached by study personnel in clinic. The study will be explained to participants by the study personnel and interested participants will be given the consent form to review.
Who may be able to join
- Able to speak and read English, Spanish, Japanese or Korean
- Patients with a biopsy-confirmed diagnosis of non-metastatic gastric or GEJ adenocarcinoma, who are scheduled to undergo MIPG or MITG for curative-intention
- Age ≥ 18
Who cannot join
- Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract
- Patients with known narcotic dependence, with average daily dose > 5 mg oral morphine equivalent
- Subjects deemed unable to comply with study and/or follow-up procedures, at investigators' discretion
- Patients who are pregnant (since are excluded from receiving standard-of-care MIPG or MITG)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
MD Anderson Cancer Center (Data Analysis Only)
Houston, Texas, 77030
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
About this study
Official title: Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
Participants will a diagnosis of gastroesophageal junction (GEJ) adenocarcinoma and will have either a minimally invasive proximal gastrectomy (MIPG) or a minimally invasive total gastrectomy (MITG) as part of their routine care. Participants with complete a questionnaire 1 month before the surgical procedure and then 1, 3, 6 and 12 months after the surgical procedure.
- Being tested
- MDASI-GI
- Keywords
- gastric cancer, non-metastatic gastric cancer, Gastroesophageal Junction Adenocarcinoma, gastroesophageal cancer, GEJ adenocarcinoma, MIPG, MITG, Minimally Invasive Proximal Gastrectomy, Minimally Invasive total gastrectomy, 23-324, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDASI-GIOther
Also called MD Anderson Symptom Inventory for gastrointestinal cancer
The MDASI-GI assesses 5 symptoms specific to gastrointestinal cancer:
constipation diarrhea or watery stools difficulty swallowing change in taste feeling bloated
Using this questionnaire, participants score the severity of their symptoms over the previous 24 hours on a scale of 0 (not present) to 10 (as bad as you can imagine).
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Proximal Gastrectomy/MIPG | Participants will undergo MIPG (Trial Procedure) Receives: Other: MDASI-GI | |
| Minimally Invasive Total Gastrectomy/MITG | Participants will undergo MITG (Standard of Care/Control Group) Receives: Other: MDASI-GI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite level score according to the MDASI-GI
The primary outcome is the appetite level score (with 0 being the best and 10 being the worst) according to the MDASi-GI at 3 months after surgery
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start8 Jan 2024
- Primary completion8 Jan 2036 (estimated)
- Study completion8 Jan 2036 (estimated)
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.
- More trials run by Memorial Sloan Kettering Cancer 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivian Strong, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243757
- Sponsor's protocol ID
- 23-324
- Status last verified
- Jul 2026
- First submitted
- 29 Jan 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
- ClinicalTrials.gov ID
- NCT06243757
- Acronym / sponsor ID
- 23-324
- Keywords
- gastric cancer, non-metastatic gastric cancer, Gastroesophageal Junction Adenocarcinoma, gastroesophageal cancer, GEJ adenocarcinoma, MIPG, MITG, Minimally Invasive Proximal Gastrectomy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 8 Jan 2036 (estimated)
- Study completion
- 8 Jan 2036 (estimated)
- First posted
- 6 Feb 2024 (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.
Participants will a diagnosis of gastroesophageal junction (GEJ) adenocarcinoma and will have either a minimally invasive proximal gastrectomy (MIPG) or a minimally invasive total gastrectomy (MITG) as part of their routine care. Participants with complete a questionnaire 1 month before the surgical procedure and then 1, 3, 6 and 12 months after the surgical procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Proximal Gastrectomy/MIPG | – | Other: MDASI-GIParticipants will undergo MIPG (Trial Procedure) |
| Minimally Invasive Total Gastrectomy/MITG | – | Other: MDASI-GIParticipants will undergo MITG (Standard of Care/Control Group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The initial contact with the potential participants will be conducted either by the treatment team, investigator or the research staff working in consultation with the treatment team. Participants will be screened in gastric and mixed tumor surgery clinics on the 5th floor of the MSKCC 53rd Street outpatient clinic building. The investigator/research staff will review portions of the medical record to determine if they are eligible. Participants who are eligible will be approached by study personnel in clinic. The study will be explained to participants by the study personnel and interested participants will be given the consent form to review.
Key inclusion criteria (3 listed)
- Able to speak and read English, Spanish, Japanese or Korean
- Patients with a biopsy-confirmed diagnosis of non-metastatic gastric or GEJ adenocarcinoma, who are scheduled to undergo MIPG or MITG for curative-intention
- Age ≥ 18
Key exclusion criteria (4 listed)
- Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract
- Patients with known narcotic dependence, with average daily dose > 5 mg oral morphine equivalent
- Subjects deemed unable to comply with study and/or follow-up procedures, at investigators' discretion
- Patients who are pregnant (since are excluded from receiving standard-of-care MIPG or MITG)
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 |
|---|---|---|
| MDASI-GIAlso: MD Anderson Symptom Inventory for gastrointestinal cancerThe MDASI-GI assesses 5 symptoms specific to gastrointestinal cancer: constipation diarrhea or watery stools difficulty swallowing change in taste feeling bloated Using this questionnaire, participants score the severity of their symptoms over the previous 24 hours on a scale of 0 (not present) to 10 (as bad as you can imagine). | Other | Minimally Invasive Proximal Gastrectomy/MIPG, Minimally Invasive Total Gastrectomy/MITG |
Primary outcome
Appetite level score according to the MDASI-GI
Time frame: 3 months after surgery
The primary outcome is the appetite level score (with 0 being the best and 10 being the worst) according to the MDASi-GI at 3 months 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 22 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Vivian Strong, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites 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 and GastroEsophageal Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
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?
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?
Appetite level score according to the MDASI-GI (time frame: 3 months after 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 22 Jul 2026.