Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan)
- Conditions
- Tumor, Solid
- Interventions
- Device: Proton Radiation Therapy
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single-arm objective performance criteria (OPC) Proton Radiation Therapy 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 does 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 whether reach the objective performance criteria (80%); the main safety evaluation index of CTCAE grade 3 toxic reaction ratio is lower than the acceptable value (5%), CTCAE grade 4 and 5 toxic reaction ratio is acceptable value (0%).
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China