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

December 17, 2020 updated by: BIRENDRA KUMAR SAH
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

232

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zhenggang Zhu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

76 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Modified SOX
Active Comparator: SURGERY FIRST
Patients undergo curative gastrectomy without any prior chemotherapy.
Procedure: Curative gastrectomy
Radical gastrectomy with D2 lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Five years
Time from randomization to death from any cause
Five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion rate of planned NAC
Time Frame: Three months
Completion rate of planned chemotherapy before surgery.
Three months
Percentage of Grade 3/4 hematological adverse events
Time Frame: Three months
Percentage of Grade 3/4 hematological adverse events during neoadjuvant chemotherapy
Three months
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
Four months
Disease-free survival (DFS)
Time Frame: Two years
Time from randomization to relapse of the disease
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BIRENDRA KUMAR SAH

Investigators

  • Study Chair: Zhenggang Zhu, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2027

Study Registration Dates

First Submitted

December 17, 2020

First Submitted That Met QC Criteria

December 17, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dragon Senile

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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