Tumor, Solid
Conditions
Keywords
Tumor, Radiation therapy, Proton therapy
Brief summary
This study is a clinical trial of prospective, single-center, single-arm objective performance criteria. This trial will be conducted with a total of 47 participants enrolled. All participants will be treated with radiation therapy using the medical device of Varian ProBeam360° Proton Therapy System (ProBeam360°), 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
Tumors sites include Intracranial, head and neck, chest, abdomen, spine, pelvic cavity, extremity and other sites. 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 which is 3 months 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.
Interventions
DEVICEProton Radiation Therapy
All enrolled participants will be treated with Proton radiation therapy using the medical device Varian ProBeam360° Proton Therapy System. 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 which is 3 months after treatment completion and long-term follow-up which is 5 years after treatment completion.
Sponsors
Varian, a Siemens Healthineers Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, open-label, non-randomized, single-arm objective performance criteria
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(Major Criteria): * Confirmed by cellular or histopathological diagnosis and/or evidence of imaging or laboratory tests, with a clinical diagnosis of benign, Patients with malignant intracranial tumors, as well as malignant solid tumors of the head and neck, chest, abdomen, spine, pelvis, and extremity; * The target lesion is a measurable solid tumor, and the longest diameter of the lesion should be ≥10mm; * Those who have an expected survival time of more than 6 months; * Eastern Cooperative Oncology Group (ECOG) physical status is graded as 0\ 2; * Females of childbearing potential with a negative blood or urine pregnancy test result within 7 days prior to the first treatment;
Exclusion criteria
(Major Criteria): * Patients with contraindications to radiation therapy, including those with a known genetic predisposition to enhance the sensitivity of normal tissue radiotherapy or concomitant conditions leading to hypersensitivity to radiotherapy * Patients with uncontrolled tumors other than the tumors to be treated, or patients with extensive metastases based on medical history or as judged by the investigator * Proton radiation therapy area includes implanted pacemakers, defibrillators, cochlear implants, drug infusion pumps, other nerve stimulators, etc. (whether turned on or not); or passive implants that affect radiotherapy * Tumor interventional treatment for the same lesion within 30 days prior to screening, such as transarterial chemoembolization (TACE), thermal ablation, etc.;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness Measure: Tumor Disease Control Rate Reaches the Objective Performance Criteria (80%) | Primary effectiveness outcome measured change from baseline to 3 months ± 7 days after treatment completion | At 3 months after the treatment completion, Disease control rate (DCR)will be assessed according to RECIST 1.1 criteria. DCR= The number of（complete response (CR)+partial response (PR)+stable disease (SD) ）/Total number of subject\*100%. Tumor assessment measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT) using Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1). CR, PR or SD were assessed through tumor size changes in CT or MRI images before and after treatment until 3-month follow-up visit. The target value for the main effectiveness evaluation (DCR) of the trial is 80% at 3 months after the end of the last radiotherapy session. If the lower limit of the 95% confidence interval of the experimental results is not less than 80%, then the DCR meets the trial Objective. |
| Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 Toxic Reaction | Primary safety outcome measured from enrollment to 3 months ± 7 days after treatment completion | The percentage of participants with CTCAE grade 3 toxic reaction should be lower than 5%. Higher than 5% means worse outcome and will be considered as failure. 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 | Primary safety outcome measured from enrollment to 3 months ± 7 days after treatment completion | The percentage of participants with toxic reaction of grade 4 and 5 should be 0%. If CTCAE grade 4 and 5 toxic reaction occured, It's not acceptable and the clinical trial is considered as failure. AEs occurred in the clinical trial are reported and scored by the investigator according to CTCAE version 5.0. |
Countries
China
Participant flow
Recruitment details
The recruitment period was from September 2024 to December 2024. 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 ProBeam360 Proton Therapy System (ProBeam360) 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 target value for efficiency should be at least 80%, with an expected 95%. Among them, the effective definition is CR+PR+SD (complete response CR, partial response PR, disease stable SD). 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.
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 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.
Therefore, long-term follow-up result will not reported here. | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Single-arm Objective Performance Criteria | — |
|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 15.78 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment China | 47 participants | — |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 26 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 47 |
| other Total, other adverse events | 40 / 47 |
| serious Total, serious adverse events | 6 / 47 |
Outcome results
Primary
Effectiveness Measure: Tumor Disease Control Rate Reaches the Objective Performance Criteria (80%)
At 3 months after the treatment completion, Disease control rate (DCR)will be assessed according to RECIST 1.1 criteria. DCR= The number of（complete response (CR)+partial response (PR)+stable disease (SD) ）/Total number of subject\*100%. Tumor assessment measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT) using Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1). CR, PR or SD were assessed through tumor size changes in CT or MRI images before and after treatment until 3-month follow-up visit. The target value for the main effectiveness evaluation (DCR) of the trial is 80% at 3 months after the end of the last radiotherapy session. If the lower limit of the 95% confidence interval of the experimental results is not less than 80%, then the DCR meets the trial Objective.
Time frame: Primary effectiveness outcome measured change from baseline to 3 months ± 7 days after treatment completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| single-arm objective performance criteria (OPC) | Effectiveness Measure: Tumor Disease Control Rate Reaches the Objective Performance Criteria (80%) | 42 Participants |
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 be considered as failure. AEs occurred in the clinical trial are recorded and scored by the investigator according to CTCAE version 5.0.
Time frame: Primary safety outcome measured from enrollment to 3 months ± 7 days after treatment completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| single-arm objective performance criteria (OPC) | 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 participants with toxic reaction of grade 4 and 5 should be 0%. If CTCAE grade 4 and 5 toxic reaction occured, It's not acceptable and the clinical trial is considered as failure. AEs occurred in the clinical trial are reported and scored by the investigator according to CTCAE version 5.0.
Time frame: Primary safety outcome measured from enrollment to 3 months ± 7 days after treatment completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| single-arm objective performance criteria (OPC) | Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction | 0 Participants |