A Study of Minimally Invasive Proximal Gastrectomy Versus Minimally Invasive Total Gastrectomy for Gastric and Gastroesophageal Junction Cancers

Gastric Cancer Clinical Trial

Official title:

Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243757
• Other study ID #: 23-324
• Status: Recruiting
• Start date: January 8, 2024
• Est. completion date: January 8, 2036

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Vivian Strong, MD
• Phone: 212-639-5056
• Email: strongv[@]MSKCC.ORG
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 8, 2036
• Est. primary completion date: January 8, 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastric Cancer
• GastroEsophageal Cancer
• Gastroesophageal Junction Adenocarcinoma
• Stomach Neoplasms

Intervention

Other:
• MDASI-GI
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).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (All Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York
United States	MD Anderson Cancer Center (Data Analysis Only)	Houston	Texas
United States	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All protocol activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activites)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months after surgery

External Links

•   Memorial Sloan Kettering Cancer Center