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

Not Applicable

Completed

• Conditions: Solid Tumor; Radiation Therapy; Proton Therapy
• Interventions: Device: Proton radiation therapy

• Registration Number: NCT05914142
• Lead Sponsor: Guangzhou Concord Cancer Center

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.

Study Timeline

• Study Start: 2022-12-15
• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-22
• Primary Completion: 2023-07-04
• Study Completion: 2023-07-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton radiation therapy group	Proton radiation therapy	Experimental: single-arm objective performance criteria, OPC

Primary Outcome Measures

Name	Time	Method
tumor disease control rate reaches the objective performance criteria	3 months ± 7 days after the last treatment	After treatment, CR, PR, SD is considered disease control; Percentage of subjects who developed disease control 3 months after the end of the last radiotherapy session.
CTCAE level 4 and 5 toxic reaction ratio is acceptable value	the entire clinical trial ( until 3 months after last treatment)	The proportion of subjects with toxic reactions of levels 4 and 5 during the clinical trial period.The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0)
CTCAE level 3 toxic reaction ratio is lower than the acceptable value	started from subject enrollment to 3 months ± 7 days after the last treatment, up to 5 months	The proportion of subjects whose toxicity reaction is level 3 during the clinical trial period. The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment	CR, PR, SD for disease control after treatment
tumor markers (if applicable), Tumor-specific symptoms	screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment	Tumor markers are examined and the researchers determine the clinical significance of reporting changes in tumor markers (before and after radiation therapy). The symptoms may be recorded according to the disease, and the researchers determine the clinical significance of reporting symptoms (before and after radiation therapy)
actual situation of Product usability evaluation (ProBeam system, Oncology Information system (OIS), Treatment plan system (Eclipse))	screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment	Researchers using the appropriate functions scored according to the Likert scale and collected open questions to evaluate the comprehensive feeling of ease of use during treatment.
tumor recurrence rate	screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment	The rate of tumor recurrence is the ratio of the number of subjects who have relapsed to the total number of subjects. The CT or MRI imaging changes of tumors before and after treatment will be evaluated by an imaging review team based on RECIST 1.1
Objective Response Rate (ORR)	screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment	The appearance of CR or PR after treatment is considered objective response, Percentage of subjects who experienced objective response at each point in time after the end of the last treatment
Duration of Response (DOR)	screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment	The duration of the tumor's first assessment as CR or PR, until the first assessment of PD or death due to any cause.
lab test, Eastern Cooperative Oncology Group (ECOG) grade	screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment	Conduct a laboratory examination and the researchers will judge the clinically significant changes in the reporting laboratory indicators. ECOG physical condition grading assessment, and the researchers judge the report of the results clinical significance of the change.
CTCAE level 1 and 2 toxic reaction ratio, Adverse Events (AE) rate, Serious Adverse Events (SAE) rate	screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment	The proportion of subjects who had toxic reactions of levels 1 and 2 during the clinical trial period.The researchers record AE that appeared during the clinical trial cycle and grade it according to CTCAE 5.0

Trial Locations

Locations (1)

Varian ProBeam 360; 🇨🇳 Guangzhou, Guangdong, China