Clinical trial NCT06243757: A Study of Minimally Invasive Proximal Gastrectomy Versus Minimally Invasive Total Gastrectomy for Gastric and Gastroesophageal Junction Cancers
Official title: Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
GastroEsophageal Cancer
Gastroesophageal Junction Adenocarcinoma
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. Participants with complete a questionnaire 1 month before the surgical procedure and then 1, 3, 6 and 12 months after the surgical procedure.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Appetite level score according to the MDASI-GI
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All protocol activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites)
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center (Data Analysis Only)
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Vivian Strong, MD
role: PRINCIPAL_INVESTIGATOR
References: