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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04677673
Recruitment Status : Not yet recruiting
First Posted : December 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
BIRENDRA KUMAR SAH, Ruijin Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Chemotherapy Effect Elderly Patients Surgery Drug: Chemotherapy Procedure: Curative gastrectomy Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: NAC PLUS SURGERY
Patients receive three cycles of the modified dose of TGO plus oxaliplatin before curative gastrectomy.
 Drug: Chemotherapy
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
Other Name: Modified SOX
Active Comparator: SURGERY FIRST
Patients undergo curative gastrectomy without any prior chemotherapy.
 Procedure: Curative gastrectomy
Radical gastrectomy with D2 lymph node dissection


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Five years ]
    Time from randomization to death from any cause


Secondary Outcome Measures :
  1. Completion rate of planned NAC [ Time Frame: Three months ]
    Completion rate of planned chemotherapy before surgery.

  2. Percentage of Grade 3/4 hematological adverse events [ Time Frame: Three months ]
    Percentage of Grade 3/4 hematological adverse events during neoadjuvant chemotherapy

  3. Pathological response [ Time Frame: Four months ]
    Total percentage of patients with pathological complete tumor regression (TRG1a) and sub-total tumor regression (TRG1b) in the primary tumor

  4. Disease-free survival (DFS) [ Time Frame: Two years ]
    Time from randomization to relapse of the disease


Eligibility Criteria
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Ages Eligible for Study:   76 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04677673


Contacts
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Contact: Birendra K Sah 0086-21-64370045 ext 6701302 rjsurgeon@hotmail.com
Contact: Zhenggang Zhu

Sponsors and Collaborators
BIRENDRA KUMAR SAH
Investigators
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Study Chair: Zhenggang Zhu Ruijin Hospital
More Information
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Responsible Party: BIRENDRA KUMAR SAH, Principal Investigator, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT04677673    
Other Study ID Numbers: Dragon Senile
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases