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

Tumor, Solid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06347731
• Other study ID #: VAR-2024-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Varian, a Siemens Healthineers Company
• Contact: Sophia Shao
• Phone: +86-21-23156400
• Email: sophia.shao[@]varian.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 47
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria (Major Criteria):

• Confirmed by cellular or histopathological diagnosis and/or evidence of imaging or laboratory tests, with a clinical diagnosis of benign, Patients with malignant intracranial tumors, as well as malignant solid tumors of the head and neck, chest, abdomen, spine, pelvis, and extremity;
• The target lesion is a measurable solid tumor, and the longest diameter of the lesion should be =10mm;
• Those who have an expected survival time of more than 6 months;
• Eastern Cooperative Oncology Group (ECOG) physical status is graded as 0~2;
• Females of childbearing potential with a negative blood or urine pregnancy test result within 7 days prior to the first treatment;

Exclusion Criteria (Major Criteria):

• Patients with contraindications to radiation therapy, including those with a known genetic predisposition to enhance the sensitivity of normal tissue radiotherapy or concomitant conditions leading to hypersensitivity to radiotherapy
• Patients with uncontrolled tumors other than the tumors to be treated, or patients with extensive metastases based on medical history or as judged by the investigator
• Proton radiation therapy area includes implanted pacemakers, defibrillators, cochlear implants, drug infusion pumps, other nerve stimulators, etc. (whether turned on or not); or passive implants that affect radiotherapy
• Tumor interventional treatment for the same lesion within 30 days prior to screening, such as transarterial chemoembolization (TACE), thermal ablation, etc.;

Related Conditions & MeSH terms

• Tumor, Solid

Intervention

Device:
• Proton Radiation Therapy
All enrolled participants will be treated with Proton radiation therapy using the medical device Varian ProBeam360° Proton Therapy System. 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Varian, a Siemens Healthineers Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness measure: tumor disease control rate reaches the objective performance criteria (80%)	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.	3 months ± 7 days after treatment completion
Primary	Safety measure: Incidence of CTCAE grade 3 toxic reaction is acceptable (lower than 5%)	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%).	from enrollment to 3 months after treatment completion
Primary	Safety measure: Incidence of CTCAE grade 4 and 5 toxic reaction is acceptable (0%)	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.	from enrollment to 3 months after treatment completion