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Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients (RJGC-Senile)

Primary Purpose

Gastric Cancer, Chemotherapy Effect, Elderly Patients

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Chemotherapy
Curative gastrectomy
Sponsored by
BIRENDRA KUMAR SAH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

76 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
  • Clinical stage: cTNM: stage III
  • Performance status: Eastern Cooperative Oncology Group ECOG ≤ 2 (normal to symptomatic but in bed less than half the day)
  • Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
  • Written informed consent

Exclusion Criteria:

  • Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
  • Distant metastases (including retroperitoneal lymph node)
  • Locally advanced inoperable disease (Clinical assessment)
  • Relapse of gastric cancer
  • Malignant secondary disease
  • Prior chemo or radiotherapy
  • Inclusion in another clinical trial
  • Known contraindications or hypersensitivity for planned chemotherapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    NAC PLUS SURGERY

    SURGERY FIRST

    Arm Description

    Patients receive three cycles of the modified dose of TGO plus oxaliplatin before curative gastrectomy.

    Patients undergo curative gastrectomy without any prior chemotherapy.

    Outcomes

    Primary Outcome Measures

    Overall Survival
    Time from randomization to death from any cause

    Secondary Outcome Measures

    Completion rate of planned NAC
    Completion rate of planned chemotherapy before surgery.
    Percentage of Grade 3/4 hematological adverse events
    Percentage of Grade 3/4 hematological adverse events during neoadjuvant chemotherapy
    Pathological response
    Total percentage of patients with pathological complete tumor regression (TRG1a) and sub-total tumor regression (TRG1b) in the primary tumor
    Disease-free survival (DFS)
    Time from randomization to relapse of the disease

    Full Information

    First Posted
    December 17, 2020
    Last Updated
    December 17, 2020
    Sponsor
    BIRENDRA KUMAR SAH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04677673
    Brief Title
    Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients
    Acronym
    RJGC-Senile
    Official Title
    Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    January 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    BIRENDRA KUMAR SAH

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.
    Detailed Description
    DRAGON SENILE research, Neoadjuvant Chemotherapy plus Surgery versus surgery first for elderly Gastric Cancer patients, is an investigator-initiated; phase II/III, open-label, randomized controlled study. The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer, Chemotherapy Effect, Elderly Patients, Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    232 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NAC PLUS SURGERY
    Arm Type
    Experimental
    Arm Description
    Patients receive three cycles of the modified dose of TGO plus oxaliplatin before curative gastrectomy.
    Arm Title
    SURGERY FIRST
    Arm Type
    Active Comparator
    Arm Description
    Patients undergo curative gastrectomy without any prior chemotherapy.
    Intervention Type
    Drug
    Intervention Name(s)
    Chemotherapy
    Other Intervention Name(s)
    Modified SOX
    Intervention Description
    Modified SOX Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 100mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 60mg/M2 oral (twice daily) Repeated every 22nd day
    Intervention Type
    Procedure
    Intervention Name(s)
    Curative gastrectomy
    Intervention Description
    Radical gastrectomy with D2 lymph node dissection
    Primary Outcome Measure Information:
    Title
    Overall Survival
    Description
    Time from randomization to death from any cause
    Time Frame
    Five years
    Secondary Outcome Measure Information:
    Title
    Completion rate of planned NAC
    Description
    Completion rate of planned chemotherapy before surgery.
    Time Frame
    Three months
    Title
    Percentage of Grade 3/4 hematological adverse events
    Description
    Percentage of Grade 3/4 hematological adverse events during neoadjuvant chemotherapy
    Time Frame
    Three months
    Title
    Pathological response
    Description
    Total percentage of patients with pathological complete tumor regression (TRG1a) and sub-total tumor regression (TRG1b) in the primary tumor
    Time Frame
    Four months
    Title
    Disease-free survival (DFS)
    Description
    Time from randomization to relapse of the disease
    Time Frame
    Two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    76 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction. Clinical stage: cTNM: stage III Performance status: Eastern Cooperative Oncology Group ECOG ≤ 2 (normal to symptomatic but in bed less than half the day) Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function. Written informed consent Exclusion Criteria: Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia Distant metastases (including retroperitoneal lymph node) Locally advanced inoperable disease (Clinical assessment) Relapse of gastric cancer Malignant secondary disease Prior chemo or radiotherapy Inclusion in another clinical trial Known contraindications or hypersensitivity for planned chemotherapy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Birendra K Sah
    Phone
    0086-21-64370045
    Ext
    6701302
    Email
    rjsurgeon@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhenggang Zhu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhenggang Zhu
    Organizational Affiliation
    Ruijin Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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