Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients
Overview
- Phase
- Phase 2
- Intervention
- Chemotherapy
- Conditions
- Gastric Cancer
- Sponsor
- BIRENDRA KUMAR SAH
- Enrollment
- 232
- Primary Endpoint
- Overall Survival
- Status
- Not Yet Recruiting
- Last Updated
- 5 years ago
Overview
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.
Investigators
BIRENDRA KUMAR SAH
Principal Investigator
Ruijin Hospital
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
Arms & Interventions
NAC PLUS SURGERY
Patients receive three cycles of the modified dose of TGO plus oxaliplatin before curative gastrectomy.
Intervention: Chemotherapy
SURGERY FIRST
Patients undergo curative gastrectomy without any prior chemotherapy.
Intervention: Curative gastrectomy
Outcomes
Primary Outcomes
Overall Survival
Time Frame: Five years
Time from randomization to death from any cause
Secondary Outcomes
- Percentage of Grade 3/4 hematological adverse events(Three months)
- Pathological response(Four months)
- Completion rate of planned NAC(Three months)
- Disease-free survival (DFS)(Two years)