Clinical trial NCT06338436: Varian ProBeam Proton Therapy System China Clinical Trial (Guangzhou)
Official title: Varian ProBeam Proton Therapy System China Clinical Trial (Guangzhou)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tumor, Solid
Keywords: Tumor
Radiation therapy
Proton therapy
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2024-03-29
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: a clinical study of prospective, single-arm objective performance criteria
Primary purpose: TREATMENT

Brief summary: This study is prospective, single-center, single-arm objective performance criteria.

This trial will be conducted 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 (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: Oncology patients, including tumors of head and neck, chest, abdomen, spine, pelvic cavity, extremities and other tumors. The screening period from informed consent to enrollment is expected to be 2 weeks, while the treatment period depends on patient medical situation and treatment plan. The period after the last treatment is divided into short-term follow-up which is 90 days 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 National Medical Products Administration (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):

* There are contraindications to radiation therapy, including congenital susceptibility to ionizing radiation hypersensitivity; or the presence of comorbidity that may lead to ionizing radiation hypersensitivity, which will increase the sensitivity of normal tissues to radiation therapy;
* The tumor recurring at the same site has received two or more radiotherapy treatments;
* Active implants such as cardiac pacemakers, defibrillators, cochlear implants, drug infusion pumps, other nerve stimulators, etc. (whether they are turned on or not) within the scope of radiotherapy ; or passive implants that affect radiotherapy thing;
* Other situations that investigator determines not suitable for enrollment

Primary outcomes:
measure: Effectiveness evaluation: Local tumor control rate 90 days after the proton radiation treatment completion
timeFrame: 90 days ± 7 days after treatment completion
measure: Safety evaluation: Incidence of Acute radiation injury
timeFrame: from enrollment to 90 days ± 7 days after treatment completion
measure: Safety evaluation: Incidence of Adverse Events based on CTCAE 5.0 criteria
timeFrame: from enrollment to 90 days ± 7 days after treatment completion
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Yimin Liu
role: PRINCIPAL_INVESTIGATOR
References: