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

Varian

Status: Enrolling

Conditions: Tumor, Solid

Treatments: Device: Proton Radiation Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06347731

VAR-2024-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

single-arm objective performance criteria (OPC)

Other group

Description:

According to the National Medical Products Administration (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 (CR)+ Partial Response (PR)+ Stable Disease (SD), and the definition of tumor disease control rate in this clinical trial is basically identical. Therefore, the clinical trial does 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 grade 3 toxic reaction ratio is lower than the acceptable value (5%), CTCAE grade 4 and 5 toxic reaction ratio is acceptable value (0%).

Treatment:

Device: Proton Radiation Therapy