NCT04549246

Grid Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities.

Spatially Fractionated Radiation (Grid) Therapy for Tumors of the Head & Neck, Thorax, Abdomen, Pelvis, and Extremities

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 83 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an observational registry study evaluating the clinical outcomes of grid therapy. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this study. Once consent has been obtained, baseline adverse event and QOL data will be collected and subjects will undergo grid therapy and follow-up at 2-4 weeks (for toxicity), and 3-6 months (for toxicities and radiographic control) then per clinical discretion up to 1 year. Patients will be evaluated according to the physician's standard practice and discretion. Patient data will be drawn from the patients' medical records and reported by means of a web-based electronic data collection (EDC) system. Patients will be considered "on study" until 60 months of observation has occurred, withdrawal of consent, lost to follow-up, or study closure. See below for the clinical visit flowchart for data collected at baseline and standard clinic visits.

Conditions

• Radiation Therapy Complication
• Tumor Neck
• Tumor Abdomen

Interventions

Type	Name	Description
RADIATION	Spatially Fractionated Radiation (GRID) Therapy	Grid therapy allows for high doses of radiation to be delivered over several spatially distinct, small regions. This permits regions of very high dose to a large tumor away from critical structures, which could be beneficial in both palliative and definitive treatments. Additionally, allowing for high doses to be delivered could pose a benefit for radioresistant histologies.

Timeline

• Start date: 2020-06-18
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2020-09-16
• Last updated: 2024-07-30

Locations

1 site across 1 country: United States