Study on the Safety and Effectiveness of Varian ProBeam Proton Therapy Equipment in the Treatment of Solid Tumors

Guangzhou Concord Cancer Center

Status: Completed

Conditions: Radiation Therapy; Solid Tumor; Proton Therapy

Treatments: Device: Proton radiation therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05914142

SYSQX-2022-046-02

Details and patient eligibility

About

This study is a clinical trial of prospective, single-arm objective performance criteria. This trial will be conducted in 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 (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis 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 will be 3 months after the end of the last treatment. Total expected participation for each subject from screening to the completion of short-term follow-up is a maximum duration of 12 weeks + 3 months. Long-term follow-up continues after the end of short-term follow-up until the 5th year after the end of the last radiotherapy session.

Enrollment: 47 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion 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.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

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

Proton radiation therapy group

Experimental group

Description:

Experimental: single-arm objective performance criteria, OPC

Treatment:

Device: Proton radiation therapy