Varian ProBeam Proton Therapy System China Clinical Trial (Hefei)

Sponsor

Varian, a Siemens Healthineers Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05463055

Collaborator

(none)

Enrollment

Location

Arm

70.1

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a clinical trial of 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 (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration.

Condition or Disease	Intervention/Treatment	Phase
Tumors	Radiation: Proton Therapy System (ProBeam)	N/A

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 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. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

47 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

a clinical study of prospective, single-arm objective performance criteriaa clinical study of prospective, single-arm objective performance criteria

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Varian ProBeam Proton Therapy System China Clinical Trial (Hefei)

Actual Study Start Date :

Dec 26, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Oct 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single-arm objective performance criteria, OPC 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 + Partial Response + Stable Disease (CR+PR+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 whether reach the objective performance criteria (80%); the main safety evaluation index of CTCAE level 3 toxic reaction ratio whether is lower than the acceptable value (5%), CTCAE level 4 and 5 toxic reaction ratio whether is acceptable value (0%).	Radiation: Proton 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.

Arm

Intervention/Treatment

Experimental: single-arm objective performance criteria, OPC

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 + Partial Response + Stable Disease (CR+PR+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 whether reach the objective performance criteria (80%); the main safety evaluation index of CTCAE level 3 toxic reaction ratio whether is lower than the acceptable value (5%), CTCAE level 4 and 5 toxic reaction ratio whether is acceptable value (0%).

Radiation: Proton 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.

Outcome Measures

Primary Outcome Measures

tumor disease control rate reaches the objective performance criteria (80%) [3 months ± 7 days after the last treatment]
After treatment, CR, PR, SD is considered disease control; Percentage of subjects who developed disease control 3 months after the end of the last radiotherapy session.
CTCAE level 3 toxic reaction ratio is lower than the acceptable value (5%) [started from subject enrollment to 3 months ± 7 days after the last treatment, up to 5 months]
The proportion of subjects whose toxicity reaction is level 3 during the clinical trial period. The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0
CTCAE level 4 and 5 toxic reaction ratio is acceptable value (0%) [the entire clinical trial ( until 5 years after last treatment)]
The proportion of subjects with toxic reactions of levels 4 and 5 during the clinical trial period.The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0

Secondary Outcome Measures

Objective Response Rate (ORR) [screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment]
The appearance of CR or PR after treatment is considered objective response, Percentage of subjects who experienced objective response at each point in time after the end of the last treatment.
Duration of Response (DOR) [screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment]
The duration of the tumor's first assessment as CR or PR, until the first assessment of PD or death due to any cause.
Disease Control Rate (DCR) [1 months ± 7 days, 2 months ± 7 days after the last treatment]
CR, PR, SD for disease control after treatment
tumor markers (if applicable), Tumor-specific symptoms [screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment]
Tumor markers are examined and the researchers determine the clinical significance of reporting changes in tumor markers (before and after radiation therapy). The symptoms may be recorded according to the disease, and the researchers determine the clinical significance of reporting symptoms (before and after radiation therapy)
actual situation of Product usability evaluation (ProBeam system, Oncology Information system (OIS), Treatment plan system (Eclipse)) [The day after the last treatment is completed.]
Researchers using the appropriate functions scored according to the Likert scale and collected open questions to evaluate the comprehensive feeling of ease of use during treatment.
CTCAE level 1 and 2 toxic reaction ratio, Adverse Events (AE) rate, Serious Adverse Events (SAE) rate [the entire clinical trial period]
The proportion of subjects who had toxic reactions of levels 1 and 2 during the clinical trial period.The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0.
lab test, Eastern Cooperative Oncology Group (ECOG) grade [screening, the 1st day or -1 day of every week before treatment during treatment period, 3 days after the last treatment, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment]
Conduct a laboratory examination and the researchers will judge the clinically significant changes in the reporting laboratory indicators. ECOG physical condition grading assessment, and the researchers judge the report of the results clinical significance of the change.
tumor recurrence rate [screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment]
The rate of tumor recurrence is the ratio of the number of subjects who have relapsed to the total number of subjects. The CT or MRI imaging changes of tumors before and after treatment will be evaluated by an imaging review team based on RECIST 1.1.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria (Major Criteria):

18≤ age≤ 80 years;
First-diagnosed patients with tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs, etc. by tissue/cell pathology;
ECOG physical condition is graded as 0 to 2;
Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment;
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):

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;
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;
Implanted pacemakers or other metal prosthesis within the scope of proton therapy;
Other situations that investigator determines not suitable for enrollment.