NCT07101666

Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Standard treatment for patients with early stage gastric cancer consists of perioperative chemotherapy and surgical resection. If radiation therapy is administered in the adjuvant setting, the radiated area is often large and associated with significant toxicity. In this study, the investigators propose the addition of short course radiation therapy (SCRT) to chemotherapy in the neoadjuvant setting. The investigators hypothesize that this regimen of Total Neoadjuvant Therapy (TNT) will result in a higher rate of complete response (both pathologic and clinical), with less toxicity.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
RADIATION	Short course radiation therapy	25 Gy in 5 fractions
DRUG	Standard of care neoadjuvant chemotherapy	Recommended options are CAPOX, FOLFOX, or FLOT but other standard of care chemotherapy may be given given at the discretion of the treating medical oncologist after consultation with the study Principal Investigator.

Timeline

• Start date: 2026-06-30
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2025-08-03
• Last updated: 2026-03-31

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study