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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-arm objective performance criteria (OPC) | Experimental | 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 (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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation: Proton Therapy System (ProBeam) | Device | 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. And long-term follow-up report will be submitted for future post market evaluation when requested by NMPA. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness evaluation: Local tumor control rate at 90 days after the proton radiation treatment completion | At 90 days after the end of treatment, 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 graded based on 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 |
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Inclusion Criteria (Major Criteria):
Exclusion Criteria (Major Criteria):
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| Name | Affiliation | Role |
|---|---|---|
| Jinming Yu | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital | Jinan | Shandong | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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a clinical study of prospective, single-arm objective performance criteria
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