Trial Title:
A Study of Minimally Invasive Proximal Gastrectomy Versus Minimally Invasive Total Gastrectomy for Gastric and Gastroesophageal Junction Cancers
NCT ID:
NCT06243757
Condition:
Gastric Cancer
GastroEsophageal Cancer
Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Conditions: 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
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
MDASI-GI
Description:
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).
Arm group label:
Minimally Invasive Proximal Gastrectomy/MIPG
Arm group label:
Minimally Invasive Total Gastrectomy/MITG
Other name:
MD Anderson Symptom Inventory for gastrointestinal cancer
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vivian Strong, MD
Phone:
212-639-5056
Facility:
Name:
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vivian Strong, MD
Phone:
212-639-5056
Facility:
Name:
Memorial Sloan Kettering Bergen (All protocol activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vivian Strong, MD
Phone:
212-639-5056
Facility:
Name:
Memorial Sloan Kettering Commack (All Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vivian Strong, MD
Phone:
212-639-5056
Facility:
Name:
Memorial Sloan Kettering Westchester (All Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vivan Strong, MD
Phone:
212-639-5056
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vivian Strong, MD
Phone:
212-639-5056
Contact backup:
Last name:
R.
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Address:
City:
Rockville Centre
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vivan Strong, MD
Phone:
212-639-5056
Facility:
Name:
MD Anderson Cancer Center (Data Analysis Only)
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Naruhiko Ikoma, MD
Phone:
713-792-2121
Email:
NIkoma@mdanderson.org
Start date:
January 8, 2024
Completion date:
January 8, 2036
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06243757
http://www.mskcc.org
