This trial will enroll 47 subjects who will be be treated with the IBA PROTEUS® PLUS Proton Beam radiation Therapy (PBT) medical device.
The trial aims to assess the safety and efficacy of PROTEUS® PLUS for radiation therapy to oncology patients, and to provide a clinical basis for product registration application.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria (main):
* Clinically diagnosed with benign/malignant intracranial tumor and malignant solid tumor of head and neck, chest, abdomen, spine, pelvic cavity and limbs
* At least 1 lesion of the tumor to be treated is measurable according to RECIST criteria
* Expected survival time of more than 6 months
* ECOG performance status of 0 to 2
* Negative pregnancy test (HCG) results within 7 days prior to the first treatment for females of childbearing potential
Exclusion Criteria (main):
* Contraindications to radiation therapy
* Presence of other uncontrolled tumors other than the tumor to be treated
* Implants and devices in the treatment area
* Re-irradiation
* Other conditions that are not suitable for inclusion, as judged by the investigator.
Primary outcome measure(s)
Short term efficacy evaluation — 90 days after the treatment completion Disease Control Rate (DCR) according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria
Short term safety evaluation — 90 days after the treatment completion Toxicity of grade 3, 4 and 5 according to CTCAE
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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