Varian ProBeam Proton Therapy System China Clinical Trial (Guangzhou)

This study is prospective, single-center, single-arm objective performance criteria.

This trial will be conducted 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.

Study Overview

• Status: Completed
• Conditions: Tumor, Solid
• Intervention / Treatment: Device: Proton Radiation Therapy System (ProBeam)

Detailed Description

Oncology patients, including tumors of head and neck, chest, abdomen, spine, pelvic cavity, extremities and other tumors. The screening period from informed consent to enrollment is expected to be 2 weeks, while the treatment period depends on patient medical situation and treatment plan. The period after the last treatment is divided into short-term follow-up which is 90 days 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 National Medical Products Administration (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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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):

• There are contraindications to radiation therapy, including congenital susceptibility to ionizing radiation hypersensitivity; or the presence of comorbidity that may lead to ionizing radiation hypersensitivity, which will increase the sensitivity of normal tissues to radiation therapy;
• The tumor recurring at the same site has received two or more radiotherapy treatments;
• Active implants such as cardiac pacemakers, defibrillators, cochlear implants, drug infusion pumps, other nerve stimulators, etc. (whether they are turned on or not) within the scope of radiotherapy ; or passive implants that affect radiotherapy thing;
• Other situations that investigator determines not suitable for enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: single-arm objective performance criteria (OPC); According to the National Medical Products Administration (NMPA) Guidance on Proton and Carbon Ion treatment system clinical evaluation and clinical trial, the objective performance criteria for the validity of medical device treatment for trial use should be at least 80%, with an expected target of 95% in which the validity is defined as: Complete Response (CR) + Partial Response (PR)+ Stable Disease (SD), and the definition of tumor disease control rate in this clinical trial is basically identical. Therefore, the clinical trial did not have a control group, but using single-arm objective performance criteria, when evaluating ProBeam radiotherapy for tumor patients, the main validity evaluation index of tumor disease control rate; the main safety evaluation by incident of acute radiation injury and adverse event.

Device: Proton Radiation Therapy System (ProBeam); All enrolled subjects will be treated with Proton radiation therapy using the medical device Varian Proton Therapy System (ProBeam). The screening period from informed consent to enrollment is expected to be 2 weeks, while the treatment period depends on patient medical situation and treatment plan. The period after the last treatment is divided into short-term follow-up which is 90 days 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness evaluation: Local tumor control rate 90 days after the proton radiation treatment completion	At 90 days 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 rated according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria.	90 days ± 7 days after treatment completion
Safety evaluation: Incidence of Acute radiation injury	Observe acute radiation injury occurrence throughout the trial period, including the treatment period and the 90-day follow-up period. Acute radiation injury will be summarized separately (calculating quantity of participants, number of cases, and incidence) based on Radiation Therapy Oncology Group (RTOG) Grading Criteria.	from enrollment to 90 days ± 7 days after treatment completion
Safety evaluation: Incidence of Adverse Events based on CTCAE 5.0 criteria	Record Incidence of Adverse Events and estimate according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0) criteria, level 3 toxic reaction ratio should be lower than the acceptable value (5%), level 4 and 5 toxic reaction should not occur.	from enrollment to 90 days ± 7 days after treatment completion

Collaborators and Investigators

• Sponsor: Varian, a Siemens Healthineers Company
• Investigators: Principal Investigator: Yimin Liu, Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2022
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Radiation therapy; Tumor; Proton therapy
• Other Study ID Numbers: VAR-2022-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No