Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan)

Not Applicable

Not yet recruiting

• Conditions: Tumor, Solid

• Registration Number: NCT06347731
• Lead Sponsor: Varian, a Siemens Healthineers Company

Brief Summary

This study is a clinical trial of prospective, single-center, single-arm objective performance criteria. This trial will be conducted with a total of 47 participants enrolled. All participants will be treated with radiation therapy using the medical device of Varian ProBeam360° Proton Therapy System (ProBeam360°), 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

Tumors sites include Intracranial, head and neck, chest, abdomen, spine, pelvic cavity, extremity and other sites. 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 which is 3 months after treatment completion and long-term follow-up which is 5 years after treatment completion. The clinical trial with short-term follow-up fulfills the requirements for NMPA regulatory registration. All the end points claimed will be achieved in the short-term follow-up stage. The trial is defined as completion once short-term follow-up is finished.

And long-term follow-up report will be submitted for future post market evaluation when requested by NMPA.

Study Timeline

• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-03-29
• Status Verified: 2024-04
• Study First Posted: 2024-04-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Study Start: 2024-07
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety measure: Incidence of CTCAE grade 3 toxic reaction is acceptable (lower than 5%)	from enrollment to 3 months after treatment completion	Record Incidence of Adverse Events and estimate according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0) criteria from enrollment to , grade 3 toxic reaction ratio should be lower than the acceptable value (5%).
Effectiveness measure: tumor disease control rate reaches the objective performance criteria (80%)	3 months ± 7 days after treatment completion	Tumor disease control rate measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT) using Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1). Tumor CT or MRI changes were assessed before and after treatment until 3-month follow-up visit.; At 3 months after the treatment completion, the number of cases in partial response (PR) and stable disease (SD) and complete response (CR) accounted for the proportion of total cases will be assessed according to RECIST 1.1 criteria.; Target value of disease control rate is 80% at 3 months after the end of the last radiotherapy session.; Disease control=CR + PR + SD.
Safety measure: Incidence of CTCAE grade 4 and 5 toxic reaction is acceptable (0%)	from enrollment to 3 months after treatment completion	Record Incidence of Adverse Events and estimate according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0) criteria, grade 4 and 5 toxic reaction should not occur.

Trial Locations

Locations (1)

Union Hospital Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China