Varian ProBeam Proton Therapy System China Clinical Trial (Hefei)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tumors

Intervention / Treatment
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* Radiation: Proton Therapy System (ProBeam)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Major Criteria): 18≤ age≤ 80 years; First-diagnosed patients with tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs, etc. by tissue/cell pathology; ECOG physical condition is graded as 0 to 2; Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment; The subject or subject's guardian is able to understand the purpose of the study, demonstrate sufficient compliance with the protocol and sign informed consent form. Exclusion Criteria (Major Criteria): The subject with radiotherapy contraindications, including the known genetic tendencies that increase the sensitivity of normal tissue radiotherapy or the accompanying diseases that lead to hypersensitivity to radiotherapy; The subject with other uncontrolled tumors except that to be treated according to medical history or the investigator's estimation, or with other malignant tumors within five years prior to enrollment; Implanted pacemakers or other metal prosthesis within the scope of proton therapy; Other situations that investigator determines not suitable for enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: a clinical study of prospective, single-arm objective performance criteria
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-arm objective performance criteria, OPC<br>According to the 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 + Partial Response + Stable Disease (CR+PR+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 whether reach the objective performance criteria (80%); the main safety evaluation index of CTCAE level 3 toxic reaction ratio whether is lower than the acceptable value (5%), CTCAE level 4 and 5 toxic reaction ratio whether is acceptable value (0%). | Radiation: Proton Therapy System (ProBeam)<br>* All of subjects (tumor patients, including tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs and other tumors) will be treated with Proton radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam). 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 ( for this trial). 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor disease control rate reaches the objective performance criteria (80%) | After treatment, CR, PR, SD is considered disease control; Percentage of subjects who developed disease control 3 months after the end of the last radiotherapy session. | 3 months ± 7 days after the last treatment | 
| CTCAE level 3 toxic reaction ratio is lower than the acceptable value (5%) | The proportion of subjects whose toxicity reaction is level 3 during the clinical trial period. The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0 | started from subject enrollment to 3 months ± 7 days after the last treatment, up to 5 months | 
| CTCAE level 4 and 5 toxic reaction ratio is acceptable value (0%) | The proportion of subjects with toxic reactions of levels 4 and 5 during the clinical trial period.The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0 | the entire clinical trial ( until 5 years after last treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | The appearance of CR or PR after treatment is considered objective response, Percentage of subjects who experienced objective response at each point in time after the end of the last treatment. | screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment | 
| Duration of Response (DOR) | The duration of the tumor's first assessment as CR or PR, until the first assessment of PD or death due to any cause. | screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment | 
| Disease Control Rate (DCR) | CR, PR, SD for disease control after treatment | 1 months ± 7 days, 2 months ± 7 days after the last treatment | 
| tumor markers (if applicable), Tumor-specific symptoms | Tumor markers are examined and the researchers determine the clinical significance of reporting changes in tumor markers (before and after radiation therapy). The symptoms may be recorded according to the disease, and the researchers determine the clinical significance of reporting symptoms (before and after radiation therapy) | screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment | 
| actual situation of Product usability evaluation (ProBeam system, Oncology Information system (OIS), Treatment plan system (Eclipse)) | Researchers using the appropriate functions scored according to the Likert scale and collected open questions to evaluate the comprehensive feeling of ease of use during treatment. | The day after the last treatment is completed. | 
| CTCAE level 1 and 2 toxic reaction ratio, Adverse Events (AE) rate, Serious Adverse Events (SAE) rate | The proportion of subjects who had toxic reactions of levels 1 and 2 during the clinical trial period.The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0. | the entire clinical trial period | 
| lab test, Eastern Cooperative Oncology Group (ECOG) grade | Conduct a laboratory examination and the researchers will judge the clinically significant changes in the reporting laboratory indicators. ECOG physical condition grading assessment, and the researchers judge the report of the results clinical significance of the change. | screening, the 1st day or -1 day of every week before treatment during treatment period, 3 days after the last treatment, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment | 
| tumor recurrence rate | The rate of tumor recurrence is the ratio of the number of subjects who have relapsed to the total number of subjects. The CT or MRI imaging changes of tumors before and after treatment will be evaluated by an imaging review team based on RECIST 1.1. | screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nervous system, head, neck, chest, abdomen, spine