Proton therapy for solid tumors using the Varian ProBeam360° system in Wuhan

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

This study is testing if the Varian ProBeam360° Proton Therapy System can safely and effectively treat different solid tumors in patients over a treatment period of 1 to 8 weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 47 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Varian, a Siemens Healthineers Company (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06347731 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of the Varian ProBeam360° Proton Therapy System for treating various solid tumors. A total of 47 participants will receive proton radiation therapy, with treatment durations ranging from 1 to 8 weeks. The study includes a short-term follow-up period of 3 months post-treatment and a long-term follow-up of up to 5 years for further evaluation. The trial aims to provide data for regulatory registration and establish a clinical basis for the device's use in oncology.

Who should consider this trial

Good fit: Ideal candidates include patients with confirmed malignant solid tumors that are measurable and have an expected survival time of more than 6 months.

Not a fit: Patients with contraindications to radiation therapy or those with conditions that increase sensitivity to radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could offer a safer and more effective treatment option for patients with solid tumors.

How similar studies have performed: Other studies have shown promising results with proton therapy for solid tumors, indicating potential success for this approach.

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.;

Where this trial is running

Wuhan, Hubei

• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Kunyu Yang — Wuhan Union Hospital, China
• Study coordinator: Sophia Shao

Conditions Tumor, Solid; Tumor; Radiation therapy; Proton therapy