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

Launched by VARIAN, A SIEMENS HEALTHINEERS COMPANY · Mar 29, 2024

Keywords

ClinConnect Summary

The Varian ProBeam360° Proton Therapy System clinical trial in Wuhan is testing a new type of radiation therapy for patients with solid tumors. The goal of the study is to see how effective and safe the ProBeam360° system is in treating various tumors, including those in the head and neck, chest, abdomen, spine, pelvis, and limbs. The trial will include 47 participants who have been diagnosed with specific types of tumors, and all participants will receive treatment using this advanced radiation technology.

To be eligible for the trial, participants must have a measurable solid tumor that is at least 10mm in size, an expected survival time of more than six months, and a good overall health status. However, individuals with certain medical conditions that make radiation therapy unsafe or those who have had recent treatments on the same tumor will not be included. Participants can expect to undergo treatment with the ProBeam360° system, and their progress will be closely monitored throughout the trial. This study aims to gather important data that could help register this medical device for wider use in treating cancer patients in the future.

Gender

ALL

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.;