Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age76+
SponsorBIRENDRA KUMAR SAH
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Chemotherapy
- Curative gastrectomy
Treatment groups
232 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
BIRENDRA KUMAR SAH
Lead sponsor
Ruijin Hospital
Sponsor institution
Source ClinicalTrials.gov