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

Last updated: October 16, 2024
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Control Group

Standard of Care

Clinical Study ID

NCT05205343
2021-0914
NCI-2022-00267
  • Ages > 18
  • All Genders

Study Summary

To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able to speak and read English or Spanish (for patients enrolled at MD Anderson andMayo Clinic), English or Korean (for patients enrolled at Yonsei), and English orJapanese (for patients enrolled at Keio)

  2. Patients with a biopsy-confirmed diagnosis of non-metastatic gastric or GEJadenocarcinoma, who are scheduled to undergo MIPG or MITG for curative-intention

  3. Age ≥ 18

Exclusion

Exclusion Criteria:

  1. Patients with known malabsorption syndromes or a lack of physical integrity of theupper gastrointestinal tract

  2. Patients with known narcotic dependence, with average daily dose > 5 mg oralmorphine equivalent

  3. Subjects deemed unable to comply with study and/or follow-up procedures, atinvestigators' discretion

  4. Patients who are pregnant (since are excluded from receiving standard-of-care MIPGor MITG)

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Control Group
Phase:
Study Start date:
May 11, 2022
Estimated Completion Date:
May 31, 2026

Study Description

Primary Objectives:

  • Delineate the short-term appetite of patients who undergo minimally-invasive proximal gastrectomy (MIPG) and compare them with those of patients with gastric and gastroesophageal adenocarcinoma who undergo total gastrectomy (MITG). We hypothesize that MIPG is associated with better postoperative appetite levels compared to MITG, which would result in improved nutritional status and maintained body weight after surgery.

Secondary Objectives:

  • Assess patient-reported outcomes (PROs) and nutrition measures. We will use the MD Anderson Symptom Inventory Gastrointestinal Cancer Module (MDASI-GI) questionnaire with additional three experimental question items ("PRO questionnaire") to collect preoperative and postoperative patient-reported outcomes (PROs) of QoL and check fasting ghrelin levels to correlate them with reported appetite levels. We will also retrospectively investigate factors associated with improved QoL after surgery, safety of MIPG and MITG, and oncological outcomes after MIPG and MITG.

Connect with a study center

  • Keio University School of Medicine

    Tokyo, 1600016
    Japan

    Active - Recruiting

  • Yonsei University College of Medicine

    Soeul, 03722
    Korea, Democratic People's Republic of

    Active - Recruiting

  • Yonsei University College of Medicine

    Soeul, 03722
    Korea, Republic of

    Active - Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Weill Cornell Medical College of Cornell University

    New York, New York 10065
    United States

    Site Not Available

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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