Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients

Conditions
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Gastric Cancer, Chemotherapy Effect, Elderly Patients, Surgery

Intervention / Treatment
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* Drug: Chemotherapy
* Procedure: Curative gastrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAC PLUS SURGERY<br>Patients receive three cycles of the modified dose of TGO plus oxaliplatin before curative gastrectomy. | Drug: Chemotherapy<br>* 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<br>* Other names: Modified SOX;|
| Active Comparator: SURGERY FIRST<br>Patients undergo curative gastrectomy without any prior chemotherapy. | Procedure: Curative gastrectomy<br>* Radical gastrectomy with D2 lymph node dissection<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate of planned NAC | Completion rate of planned chemotherapy before surgery. | Three months | 
| Percentage of Grade 3/4 hematological adverse events | Percentage of Grade 3/4 hematological adverse events during neoadjuvant chemotherapy | Three months | 
| Pathological response | 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 from randomization to relapse of the disease | Two years |