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

NCT04677673 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Dragon Senile
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastric Cancer; Chemotherapy Effect; Elderly Patients; Surgery

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Time from randomization to death from any cause

  Five years

Secondary Outcomes (4)

• Completion rate of planned NAC

  Three months

• Percentage of Grade 3/4 hematological adverse events

  Three months

• Pathological response

  Four months

• Disease-free survival (DFS)

  Two years

Study Arms (2)

NAC PLUS SURGERY

EXPERIMENTAL

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

Drug: Chemotherapy

SURGERY FIRST

ACTIVE COMPARATOR

Patients undergo curative gastrectomy without any prior chemotherapy.

Procedure: Curative gastrectomy

Interventions

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

Also known as: Modified SOX

NAC PLUS SURGERY

Curative gastrectomy PROCEDURE

Radical gastrectomy with D2 lymph node dissection

SURGERY FIRST

Eligibility Criteria

• Age: 76 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Known contraindications or hypersensitivity for planned chemotherapy

Sponsors & Collaborators

• BIRENDRA KUMAR SAH: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zhenggang Zhu

  Ruijin Hospital

  STUDY CHAIR

Central Study Contacts

Birendra K Sah

CONTACT

0086-21-64370045; rjsurgeon@hotmail.com

Zhenggang Zhu

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 21, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share