Clinical trial NCT06340815: Varian ProBeam Proton Therapy System Clinical Trial (Shandong)
Official title: Varian ProBeam Proton Therapy System Clinical Trial (Shandong)
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: 2024-04-02
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):

1. Patients diagnosed with histological/pathological diagnosis and/or with imaging, laboratory examination and other evidence, clinically diagnosed as benign and malignant intracranial tumors, and malignant solid tumors of the head and neck, chest, abdomen, spine, pelvis, and extremities;
2. Eastern Cooperative Oncology Group (ECOG) physical condition grade ≤ 2;
3. Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment;
4. The subject or subject's guardian is able to understand the purpose of the study, demonstrate sufficient compliance with the protocol and sign informed consent form.

Exclusion Criteria (Major Criteria):

1. 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;
2. The tumor recurring at the same site has received two or more radiotherapy treatments;
3. 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;
4. Other situations that investigator determines not suitable for enrollment.

Primary outcomes:
measure: Effectiveness evaluation: Local tumor control rate at 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: Shanghai
country: China
facility: Sophia Shao
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Jinming Yu
role: PRINCIPAL_INVESTIGATOR
References: