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This study is 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 to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing clinical evidence for the medical device registration.
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 is 3 months after treatment completion and long-term follow-up is 5 years after the end of the last radiotherapy session.
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 finished.
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 | Experimental | According to the National Medical Products Administration (NMPA) Guidance on Proton and Carbon Ion treatment system clinical evaluation and clinical trial, the participants with disease control should be at least 95%. The primary safety endpoints is that participants with Common Terminology Criteria for Adverse Events (CTCAE) grade 3 toxic reaction should be lower than 5%, CTCAE grade 4 and 5 toxic reaction rate is 0%. Therefore, the clinical trial did not have a control group, but using single-arm objective performance criteria. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Therapy System (ProBeam) | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Disease Control | Disease control refers to partial response and stable disease and complete response. Percentage of participants with disease control should be at least 95%. Tumor disease control measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CT or MRI changes will be assessed before and after treatment. | 3 months ± 7 days after treatment completion, up to 24 weeks |
| Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 Toxic Reaction | The percentage of participants with CTCAE grade 3 toxic reaction should be lower than 5%. Higher than 5% means worse outcome and will not be accepted. AEs occurred in the clinical trial are recorded and scored by the investigator according to CTCAE version 5.0. | From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks |
| Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction | The percentage of subjects with toxic reactions of levels 4 and 5 should be 0%. If CTCAE level 4 and 5 toxic reaction occured, the clinical trial is considered as failure. AEs occurred in the clinical trial are reported and scored by the investigator according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks |
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Inclusion Criteria (Major Criteria):
Exclusion Criteria (Major Criteria):
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| Name | Affiliation | Role |
|---|---|---|
| Hongyan Zhang | Anhui Provincial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230001 | China |
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Subjects meeting the inclusion/exclusion criteria and enrolled in the trial were treated with ProBeam Proton Therapy System (ProBeam) unless the subject's status isn't fit for proton therapy prior to treatment during treatment planning and target area confirming. For example, if the subject's treatment plan indicated that within the target area wasn't suitable for radiation therapy, then should preclude from the trial.
The recruitment period was from December 2021 to June 2022. The location of the study was in medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-arm Objective Performance Criteria | The primary effectiveness for clinical trial should be 95% participants with disease control, which includes Complete Response, Partial Response and Stable Disease. The primary safety endpoints is that participants with Common Terminology Criteria for Adverse Events (CTCAE) grade 3 toxic reaction should be lower than 5%, CTCAE level 4 and 5 toxic reaction rate is 0%. Therefore, the clinical trial did not have a control group, but using single-arm objective performance criteria. Participants enrolled will be treated with Proton radiation therapy. The period after the last treatment is divided into short-term follow-up and long-term follow-up, in which short-term follow-up is 3 months and long-term follow-up 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 finished. Long-term follow-up report will be submitted for future post market evaluation when requested by National Medical Products Administration (NMPA). Therefore, long-term follow-up result will not be reported here. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-arm Objective Performance Criteria | The primary effectiveness for clinical trial should be 95% participants with disease control, which includes Complete Response, Partial Response and Stable Disease. The primary safety endpoints is that participants with Common Terminology Criteria for Adverse Events (CTCAE) grade 3 toxic reaction should be lower than 5%, CTCAE level 4 and 5 toxic reaction rate is 0%. Therefore, the clinical trial did not have a control group, but using single-arm objective performance criteria. All enrolled subjects were treated with ProBeam Proton Therapy System. The period after the last treatment is divided into short-term follow-up and long-term follow-up, in which short-term follow-up is 3 months after treatment completion and long-term follow-up 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 finished. Long-term follow-up report will be submitted for future post market evaluation when requested by NMPA. Therefore, long-term follow-up result will not reported here. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Disease Control | Disease control refers to partial response and stable disease and complete response. Percentage of participants with disease control should be at least 95%. Tumor disease control measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CT or MRI changes will be assessed before and after treatment. | Posted | Number | 95% Confidence Interval | percentage | 3 months ± 7 days after treatment completion, up to 24 weeks |
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The clinical trial started from subject enrollment to 3 months ± 7 days after the last treatment, up to 24 weeks. Long-term follow-up report (from 3-month follow-up till 5 years) will be submitted for future post market evaluation when requested by NMPA. Therefore, long-term follow-up result will not be reported here.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-arm Objective Performance Criteria | The primary effectiveness for clinical trial should be 95% participants with disease control, which includes Complete Response, Partial Response and Stable Disease. The primary safety endpoints is that participants with Common Terminology Criteria for Adverse Events (CTCAE) level 3 toxic reaction should be lower than 5%, CTCAE level 4 and 5 toxic reaction rate is 0%. Therefore, the clinical trial did not have a control group, but using single-arm objective performance criteria. Subjects enrolled in the trial will be treated with Proton radiation therapy. The period after the last treatment is divided into short-term follow-up and long-term follow-up, in which short-term follow-up is 3 months and long-term follow-up 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 finished. Long-term follow-up report will be submitted for future post market evaluation when requested by National Medical Products Administration (NMPA). Therefore, long-term follow-up result will not be reported here. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radiation dermatitis | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sophia Shao | Varian Medical Systems | +86-21-23156400 | sophia.shao@varian.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2022 | Mar 29, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2022 | Mar 29, 2024 | SAP_001.pdf |
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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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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| single-arm objective performance criteria | Count of Participants | Participants |
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| Primary | Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 Toxic Reaction | The percentage of participants with CTCAE grade 3 toxic reaction should be lower than 5%. Higher than 5% means worse outcome and will not be accepted. AEs occurred in the clinical trial are recorded and scored by the investigator according to CTCAE version 5.0. | Posted | Count of Participants | Participants | From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks |
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| Primary | Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction | The percentage of subjects with toxic reactions of levels 4 and 5 should be 0%. If CTCAE level 4 and 5 toxic reaction occured, the clinical trial is considered as failure. AEs occurred in the clinical trial are reported and scored by the investigator according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Posted | Count of Participants | Participants | From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks |
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| 0 |
| 47 |
| 1 |
| 47 |
| 9 |
| 47 |
| Radiation mucositis | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| hair loss | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Low White blood cell count | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Increased skin pigmentation | General disorders | MedDRA 25.0 | Systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release. Sponsor have the right to require Principal Investigator, as applicable, to remove specifically identified Confidential Information (other than Trial Data) and/or to delay the proposed publication, presentation or other public disclosure for an additional sixty (60) days to enable Sponsor to seek patent protection.