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

ConditionsGastric CancerChemotherapy EffectElderly PatientsSurgery
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Chemotherapy

    Drug

    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

  • Curative gastrectomy

    Procedure/Surgery

    Radical gastrectomy with D2 lymph node dissection

Treatment groups

232 Participants
are divided into 2 treatment groups
Group A: NAC PLUS SURGERYExperimental treatment 1 intervention
Group B: SURGERY FIRSTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

Time from randomization to death from any cause

Time frame
Five years

Secondary outcomes

1

Completion rate of planned NAC

Completion rate of planned chemotherapy before surgery.

Time frame
Three months
2

Percentage of Grade 3/4 hematological adverse events

Percentage of Grade 3/4 hematological adverse events during neoadjuvant chemotherapy

Time frame
Three months
3

Pathological response

Total percentage of patients with pathological complete tumor regression (TRG1a) and sub-total tumor regression (TRG1b) in the primary tumor

Time frame
Four months
4

Disease-free survival (DFS)

Time from randomization to relapse of the disease

Time frame
Two years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BIRENDRA KUMAR SAH

Lead sponsor

Ruijin Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: