NCT04162665

Pre-operative Adaptive Short Court Radiation Therapy in Gastric Cancer

Pre-operative Adaptive Short Course Radiation Therapy in Gastric Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Gastric cancer is a global health issue as the world's fifth most common malignancy and third leading cause of cancer mortality, respectively. Preoperative radiation therapy may improve overall survival (OS) but is seldom used. There is precedent for preoperative chemoradiation, as it is the standard of care for esophageal and gastroesophageal junction tumors. However, reluctance of physicians to prescribe preoperative radiation therapy in gastric cancer may be due to the large treatment fields necessary to account for stomach motion. Adaptive radiation therapy may permit decreased field sizes and more accurate dose delivery. In traditional CT based radiation delivery the same radiation plan is delivered each day without assessment of inter-fraction or intra-fraction motion. Adaptive radiation therapy permits the physician to contour the unique anatomy daily to generate a new plan to account for day to day organ motion. Real-time MR imaging is also used during the treatment so that radiation is only delivered when the tumor is within the pre-specified target area. Thus, adaptive radiation therapy may overcome traditional barriers of radiation delivery in gastric cancer and improve oncologic outcomes.

Conditions

• Gastric Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	Adaptive short course radiation therapy	Radiation must be livered with adaptive planning and MR gating or CBCT breath hold treatment.
DRUG	Standard of care chemotherapy regimen	The recommendations are CAPOX, FOLFOX, or FLT.

Timeline

• Start date: 2020-02-14
• Primary completion: 2023-12-18
• Completion: 2024-11-21
• First posted: 2019-11-14
• Last updated: 2025-01-09
• Results posted: 2025-01-09

Locations

1 site across 1 country: United States

Regulatory

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