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Search / Trial NCT04677673

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

Launched by BIRENDRA KUMAR SAH · Dec 17, 2020

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat elderly patients with locally advanced gastric cancer, which is a type of stomach cancer. Researchers want to find out if giving chemotherapy (a treatment that uses powerful drugs to kill cancer cells) before surgery is more effective than just doing surgery first. This chemotherapy regimen is known as modified SOX. The trial aims to see if this approach is safe and beneficial for older patients facing this illness.

To be eligible for the trial, participants need to have a specific type of stomach cancer that has not caused a blockage and is at an advanced stage (stage III). They should be in reasonably good health, meaning they can handle both chemotherapy and surgery without major health issues. However, those with severe heart problems, other uncontrolled diseases, or prior treatments for cancer won't be included. If someone joins the trial, they can expect to receive the chemotherapy before their surgery and will be monitored closely throughout the process. This trial is not yet recruiting participants, so more details will be available as it gets underway.

Gender

ALL

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

About Birendra Kumar Sah

Birendra Kumar Sah is a dedicated clinical trial sponsor with a commitment to advancing medical research and improving patient outcomes. With extensive experience in trial design and implementation, he focuses on innovative therapeutic areas and adheres to the highest ethical standards. His leadership fosters collaboration among multidisciplinary teams, ensuring rigorous adherence to regulatory requirements and a patient-centered approach. Through strategic partnerships and a robust infrastructure, Birendra Kumar Sah aims to contribute significantly to the development of safe and effective treatments, ultimately enhancing the quality of healthcare.

Locations

Patients applied

0 patients applied

Trial Officials

Zhenggang Zhu

Study Chair

Ruijin Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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