Trial Outcomes & Findings for Varian ProBeam Proton Therapy System China Clinical Trial (Hefei) (NCT NCT05463055)
NCT ID: NCT05463055
Last Updated: 2024-11-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
3 months ± 7 days after treatment completion, up to 24 weeks
Results posted on
2024-11-15
Participant Flow
The recruitment period was from December 2021 to June 2022. The location of the study was in medical clinic.
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Varian ProBeam Proton Therapy System China Clinical Trial (Hefei)
Baseline characteristics by cohort
| Measure |
Single-arm Objective Performance Criteria
n=47 Participants
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.
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|---|---|
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Age, Continuous
|
51.7 years
STANDARD_DEVIATION 14.09 • n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Han of Chinese
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47 Participants
n=99 Participants
|
|
single-arm objective performance criteria
|
47 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 months ± 7 days after treatment completion, up to 24 weeksDisease 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.
Outcome measures
| Measure |
Single-arm Objective Performance Criteria
n=45 Participants
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.
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.
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|---|---|
|
Percentage of Participants With Disease Control
|
100 percentage
Interval 92.1 to 100.0
|
PRIMARY outcome
Timeframe: From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeksThe 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.
Outcome measures
| Measure |
Single-arm Objective Performance Criteria
n=47 Participants
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.
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.
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|---|---|
|
Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 Toxic Reaction
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0 Participants
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PRIMARY outcome
Timeframe: From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeksThe 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.
Outcome measures
| Measure |
Single-arm Objective Performance Criteria
n=47 Participants
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.
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.
|
|---|---|
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Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction
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0 Participants
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Adverse Events
Single-arm Objective Performance Criteria
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single-arm Objective Performance Criteria
n=47 participants at risk
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.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
pneumonia
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2.1%
1/47 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Single-arm Objective Performance Criteria
n=47 participants at risk
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.
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|---|---|
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Injury, poisoning and procedural complications
Radiation dermatitis
|
19.1%
9/47 • Number of events 9 • 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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|
Injury, poisoning and procedural complications
Radiation mucositis
|
6.4%
3/47 • Number of events 3 • 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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General disorders
hair loss
|
6.4%
3/47 • Number of events 3 • 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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Blood and lymphatic system disorders
Low White blood cell count
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4.3%
2/47 • Number of events 2 • 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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General disorders
Increased skin pigmentation
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4.3%
2/47 • Number of events 2 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER