Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan)

Trial Title: Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan)

NCT ID: NCT06347731

Condition: Tumor, Solid

Conditions: Keywords:
Tumor
Radiation therapy
Proton therapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: prospective, open-label, non-randomized, single-arm objective performance criteria

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Proton Radiation Therapy
Description: 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.
Arm group label: single-arm objective performance criteria (OPC)

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.

Criteria for eligibility:
Criteria:
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.;

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Union Hospital Tongji Medical College Huazhong University of Science and Technology

Address:
City: Wuhan
Country: China

Status: Recruiting

Contact:
Last name: Yang Kunyu

Start date: August 29, 2024

Completion date: March 2025

Lead sponsor:
Agency: Varian, a Siemens Healthineers Company
Agency class: Industry

Source: Varian, a Siemens Healthineers Company

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06347731