Varian ProBeam Proton Therapy System Clinical Trial (Shandong)

Tumor, Solid Clinical Trial

Official title:

Varian ProBeam Proton Therapy System Clinical Trial (Shandong)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06340815
• Other study ID #: VAR-2022-02
• Status: Completed
• Phase: N/A
• Start date: July 20, 2022
• Est. completion date: March 10, 2023

Study information

• Verified date: March 2024
• Source: Varian, a Siemens Healthineers Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is prospective, single-center, single-arm objective performance criteria.

This trial will be conducted 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.

Description:

Oncology patients, including tumors of head and neck, chest, abdomen, spine, pelvic cavity, extremities and other tumors. The screening period from informed consent to enrollment is expected to be 2 weeks, while the treatment period depends on patient medical situation and treatment plan. The period after the last treatment is divided into short-term follow-up which is 90 days 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 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 is finished.

And long-term follow-up report will be submitted for future post market evaluation when requested by NMPA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 10, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria (Major Criteria):

1. Patients diagnosed with histological/pathological diagnosis and/or with imaging, laboratory examination and other evidence, clinically diagnosed as benign and malignant intracranial tumors, and malignant solid tumors of the head and neck, chest, abdomen, spine, pelvis, and extremities;

2. Eastern Cooperative Oncology Group (ECOG) physical condition grade = 2;

3. Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment;

4. 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. There are contraindications to radiation therapy, including congenital susceptibility to ionizing radiation hypersensitivity; or the presence of comorbidity that may lead to ionizing radiation hypersensitivity, which will increase the sensitivity of normal tissues to radiation therapy;

2. The tumor recurring at the same site has received two or more radiotherapy treatments;

3. Active implants such as cardiac pacemakers, defibrillators, cochlear implants, drug infusion pumps, other nerve stimulators, etc. (whether they are turned on or not) within the scope of radiotherapy ; or passive implants that affect radiotherapy thing;

4. Other situations that investigator determines not suitable for enrollment.

Related Conditions & MeSH terms

• Tumor, Solid

Intervention

Device:
• Radiation: Proton Therapy System (ProBeam)
All enrolled subjects will be treated with Proton radiation therapy using the medical device Varian Proton Therapy System (ProBeam). The screening period from informed consent to enrollment is expected to be 2 weeks, while the treatment period depends on patient medical situation and treatment plan. The period after the last treatment is divided into short-term follow-up which is 90 days 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.

Locations

Country	Name	City	State
China	Sophia Shao	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Varian, a Siemens Healthineers Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness evaluation: Local tumor control rate at 90 days after the proton radiation treatment completion	At 90 days after the end of treatment, the number of cases in partial response (PR) and stable disease (SD) and complete response (CR) accounted for the proportion of total cases will be graded based on Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria.	90 days ± 7 days after treatment completion
Primary	Safety evaluation: Incidence of Acute radiation injury	Observe acute radiation injury occurrence throughout the trial period, including the treatment period and the 90-day follow-up period. Acute radiation injury will be summarized separately (calculating quantity of participants, number of cases, and incidence) based on Radiation Therapy Oncology Group (RTOG) Grading Criteria.	from enrollment to 90 days ± 7 days after treatment completion
Primary	Safety evaluation: Incidence of Adverse Events based on CTCAE 5.0 criteria	record Incidence of Adverse Events and estimate according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0) criteria, level 3 toxic reaction ratio should be lower than the acceptable value (5%), level 4 and 5 toxic reaction should not occur.	from enrollment to 90 days ± 7 days after treatment completion