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

Phase 2

Not yet recruiting

• Conditions: Chemotherapy Effect; Surgery; Gastric Cancer; Elderly Patients
• Interventions: Drug: Chemotherapy; Procedure: Curative gastrectomy

• Registration Number: NCT04677673
• Lead Sponsor: BIRENDRA KUMAR SAH

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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-17
• Last Update Submitted: 2020-12-17
• Study First Posted: 2020-12-21
• Last Update Posted: 2020-12-21
• Study Start: 2021-01
• Primary Completion: 2022-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 232

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAC PLUS SURGERY	Chemotherapy	Patients receive three cycles of the modified dose of TGO plus oxaliplatin before curative gastrectomy.
SURGERY FIRST	Curative gastrectomy	Patients undergo curative gastrectomy without any prior chemotherapy.

Primary Outcome Measures

Name	Time	Method
Overall Survival	Five years	Time from randomization to death from any cause

Secondary Outcome Measures

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