NCT05914142

Study on the Safety and Effectiveness of Varian ProBeam Proton Therapy Equipment in the Treatment of Solid Tumors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Guangzhou Concord Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a clinical trial of prospective, single-arm objective performance criteria. This trial will be conducted in clinical trial sites with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration.

Detailed description

Oncology patients, including tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs and other tumors. The screening period from informed consent to enrollment is expected to be 4 weeks, while the treatment period is 1 to 8 weeks. The period after the last treatment is divided into short-term follow-up and long-term follow-up, in which short-term follow-up will be 3 months after the end of the last treatment. Total expected participation for each subject from screening to the completion of short-term follow-up is a maximum duration of 12 weeks + 3 months. Long-term follow-up continues after the end of short-term follow-up until the 5th year after the end of the last radiotherapy session.

Conditions

• Solid Tumor
• Radiation Therapy
• Proton Therapy

Interventions

Type	Name	Description
DEVICE	Proton radiation therapy	Radiation: Proton Therapy System (ProBeam)

Timeline

• Start date: 2022-12-15
• Primary completion: 2023-07-04
• Completion: 2023-07-04
• First posted: 2023-06-22
• Last updated: 2023-11-07

Locations

1 site across 1 country: China