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

BIRENDRA KUMAR SAH

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Chemotherapy Effect; Gastric Cancer; Surgery; Elderly Patients

Treatments: Procedure: Curative gastrectomy; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04677673

Dragon Senile

Details and patient eligibility

About

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.

Full 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.

Enrollment: 232 estimated patients

Sex: All

Ages: 76+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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232 participants in 2 patient groups

NAC PLUS SURGERY

Experimental group

Description:

Patients receive three cycles of the modified dose of TGO plus oxaliplatin before curative gastrectomy.

Treatment:

Drug: Chemotherapy

SURGERY FIRST

Active Comparator group

Description:

Patients undergo curative gastrectomy without any prior chemotherapy.

Treatment:

Procedure: Curative gastrectomy