Tumor, Solid
Conditions
Keywords
Tumor, Radiation therapy, Proton therapy
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.
Interventions
DEVICERadiation: Proton Therapy System (ProBeam)
All enrolled subjects will be treated with Proton radiation therapy using the medical device Varian Proton Therapy System (ProBeam). 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 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.
Sponsors
Varian, a Siemens Healthineers Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
a clinical study of prospective, single-arm objective performance criteria
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness evaluation: Local tumor control rate at 90 days after the proton radiation treatment completion | 90 days ± 7 days after treatment completion | At 90 days after the end of treatment, the number of cases in partial response (PR) and stable disease (SD) and complete response (CR) accounted for the proportion of total cases will be graded based on Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria. |
| Safety evaluation: Incidence of Acute radiation injury | from enrollment to 90 days ± 7 days after treatment completion | Observe acute radiation injury occurrence throughout the trial period, including the treatment period and the 90-day follow-up period. Acute radiation injury will be summarized separately (calculating quantity of participants, number of cases, and incidence) based on Radiation Therapy Oncology Group (RTOG) Grading Criteria. |
| Safety evaluation: Incidence of Adverse Events based on CTCAE 5.0 criteria | from enrollment to 90 days ± 7 days after treatment completion | record Incidence of Adverse Events and estimate according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0) criteria, level 3 toxic reaction ratio should be lower than the acceptable value (5%), level 4 and 5 toxic reaction should not occur. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJinming Yu
Shandong Cancer Hospital and Institute
Outcome results
None listed