Clinical trial NCT05914142: Study on the Safety and Effectiveness of Varian ProBeam Proton Therapy Equipment in the Treatment of Solid Tumors
Official title: Study on the Safety and Effectiveness of Varian ProBeam Proton Therapy Equipment in the Treatment of Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Tumor
Radiation Therapy
Proton Therapy
Keywords: varian
Probeam
Lead sponsor: Guangzhou Concord Cancer Center
Sponsor class: OTHER
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Varian, a Siemens Healthineers Company
First posted: 2023-06-22
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
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: tumor disease control rate reaches the objective performance criteria
timeFrame: 3 months ± 7 days after the last treatment
measure: CTCAE level 3 toxic reaction ratio is lower than the acceptable value
timeFrame: started from subject enrollment to 3 months ± 7 days after the last treatment, up to 5 months
measure: CTCAE level 4 and 5 toxic reaction ratio is acceptable value
timeFrame: the entire clinical trial ( until 3 months after last treatment)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
measure: Duration of Response (DOR)
timeFrame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
measure: Disease Control Rate (DCR)
timeFrame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
measure: tumor markers (if applicable), Tumor-specific symptoms
timeFrame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
measure: actual situation of Product usability evaluation (ProBeam system, Oncology Information system (OIS), Treatment plan system (Eclipse))
timeFrame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
measure: CTCAE level 1 and 2 toxic reaction ratio, Adverse Events (AE) rate, Serious Adverse Events (SAE) rate
timeFrame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
measure: lab test, Eastern Cooperative Oncology Group (ECOG) grade
timeFrame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
measure: tumor recurrence rate
timeFrame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Varian ProBeam 360
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Yimin Liu, Professor
role: STUDY_DIRECTOR
affiliation: Guangzhou Concord Cancer Center
name: Shen Fu, Professor
role: STUDY_DIRECTOR
References: