Varian ProBeam Proton Therapy System China Clinical Trial (Hefei)

Varian

Status: Completed

Conditions: Tumor, Solid

Treatments: Radiation: Proton Therapy System (ProBeam)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05463055

VAR-2021-03

Details and patient eligibility

About

This study is prospective, two-center, single-arm objective performance criteria. This trial will be conducted in 2 clinical trial sites 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 to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing clinical evidence for the medical device registration.

Full description

Oncology patients, including tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs and other tumors. 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 and long-term follow-up, in which short-term follow-up is 3 months after treatment completion and long-term follow-up is 5 years after the end of the last radiotherapy session.

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 finished.

Long-term follow-up report will be submitted for future post market evaluation when requested by NMPA.

Enrollment: 47 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Major Criteria):

1. 18≤ age≤ 80 years;
2. First-diagnosed patients with tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs, etc. by tissue/cell pathology;
3. Eastern Cooperative Oncology Group (ECOG) physical condition is graded as 0 to 2;
4. Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment;
5. 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. The subject with radiotherapy contraindications, including the known genetic tendencies that increase the sensitivity of normal tissue radiotherapy or the accompanying diseases that lead to hypersensitivity to radiotherapy;
2. The subject with other uncontrolled tumors except that to be treated according to medical history or the investigator's estimation, or with other malignant tumors within five years prior to enrollment;
3. Implanted pacemakers or other metal prosthesis within the scope of proton therapy;
4. Other situations that investigator determines not suitable for enrollment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

single-arm objective performance criteria

Experimental group

Description:

According to the National Medical Products Administration (NMPA) Guidance on Proton and Carbon Ion treatment system clinical evaluation and clinical trial, the participants with disease control should be at least 95%. The primary safety endpoints is that participants with Common Terminology Criteria for Adverse Events (CTCAE) grade 3 toxic reaction should be lower than 5%, CTCAE grade 4 and 5 toxic reaction rate is 0%. Therefore, the clinical trial did not have a control group, but using single-arm objective performance criteria.

Treatment:

Radiation: Proton Therapy System (ProBeam)