At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 80 years
- ✓First-diagnosed patients with confirmed solid tumors (nervous system, head and neck, chest, abdomen, spine, pelvis, limbs, or other sites) by tissue or cell pathology
- ✓ECOG performance status 0–2
- ✓Negative serum pregnancy test (HCG) within 7 days prior to first treatment (women of childbearing age)
- ✕Radiotherapy contraindications, including known genetic radiosensitivity syndromes or concurrent diseases causing hypersensitivity to radiotherapy
- ✕Other uncontrolled malignancies or second malignancy within 5 years prior to enrollment (except the tumor to be treated)
- ✕Implanted pacemakers or metal prosthesis within the proton therapy treatment field
- ✕Any other condition the investigator deems unsuitable for enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Varian ProBeam Proton Therapy System China Clinical Trial (Hefei)
In Brief
A clinical study evaluating Proton Therapy System (ProBeam) for Tumor, Solid. Completed, enrolled 47 participants across 1 site.
Detailed Summary
This study is prospective, two-center, single-arm objective performance criteria. This trial will be conducted in 2 clinical trial sites 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 to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing clinical evidence for the medical device registration.
Study Details
Timeline
Interventions
All of subjects (tumor patients, including tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs and other tumors) will be treated with Proton radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam). 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 and long-term follow-up, in which short-term follow-up will be 3 months after the end of the last treatment. Total expected participation for each subject from screening to the completion of short-term follow-up is a maximum duration of 12 weeks + 3 months ( for this trial). Long-term follow-up continues after the end of short-term follow-up until the 5th year after the end of the last radiotherapy session.