Clinical trial NCT06347731: Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan)
Official title: Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tumor, Solid
Keywords: Tumor
Radiation therapy
Proton therapy
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, open-label, non-randomized, single-arm objective performance criteria
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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.;

Primary outcomes:
measure: Effectiveness measure: tumor disease control rate reaches the objective performance criteria (80%)
timeFrame: 3 months ± 7 days after treatment completion
measure: Safety measure: Incidence of CTCAE grade 3 toxic reaction is acceptable (lower than 5%)
timeFrame: from enrollment to 3 months after treatment completion
measure: Safety measure: Incidence of CTCAE grade 4 and 5 toxic reaction is acceptable (0%)
timeFrame: from enrollment to 3 months after treatment completion
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Kunyu Yang
role: PRINCIPAL_INVESTIGATOR
References: