Varian ProBeam Proton Therapy System China Clinical Trial (Hefei) — ProBeam  

Tumors Clinical Trial

Official title: Varian ProBeam Proton Therapy System China Clinical Trial (Hefei)

Status Completed

Clinical Trial Summary

This study is a clinical trial of prospective, two-center, single-arm objective performance criteria. This trial will be conducted in 2 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Tumors

• NCT number: NCT05463055
• Study type: Interventional
• Source: Varian, a Siemens Healthineers Company
• Status: Completed
• Phase: N/A
• Start date: December 26, 2021
• Completion date: November 3, 2022