Tumor, Solid
Conditions
Keywords
Proton therapy, Radiation therapy, Tumor
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONProton Therapy System (ProBeam)
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.
Sponsors
Varian, a Siemens Healthineers Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
a clinical study of prospective, single-arm objective performance criteria
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(Major Criteria): 1. 18≤ age≤ 80 years; 2. First-diagnosed patients with tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs, etc. by tissue/cell pathology; 3. Eastern Cooperative Oncology Group (ECOG) physical condition is graded as 0 to 2; 4. Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment; 5. 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): 1. 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; 2. 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; 3. Implanted pacemakers or other metal prosthesis within the scope of proton therapy; 4. Other situations that investigator determines not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Disease Control | 3 months ± 7 days after treatment completion, up to 24 weeks | 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. |
| Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 Toxic Reaction | From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks | 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. |
| Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction | From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks | 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. |
Countries
China
Participant flow
Recruitment details
The recruitment period was from December 2021 to June 2022. The location of the study was in medical clinic.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Single-arm Objective Performance Criteria |
|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 14.09 |
| Race/Ethnicity, Customized Han of Chinese | 47 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 27 Participants |
| single-arm objective performance criteria | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 9 / 47 |
| serious Total, serious adverse events | 1 / 47 |
Outcome results
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.
Time frame: From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single-arm Objective Performance Criteria | Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 Toxic Reaction | 0 Participants |
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.
Time frame: From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single-arm Objective Performance Criteria | Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction | 0 Participants |
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.
Time frame: 3 months ± 7 days after treatment completion, up to 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-arm Objective Performance Criteria | Percentage of Participants With Disease Control | 100 percentage |