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

NCT05914142 | Completed

• 1 other identifier: SYSQX-2022-046-02
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor; Radiation Therapy; Proton Therapy

Keywords

varian; Probeam

Outcome Measures

Primary Outcomes (3)

• tumor disease control rate reaches the objective performance criteria

  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.

  3 months ± 7 days after the last treatment

• CTCAE level 3 toxic reaction ratio is lower than the acceptable value

  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

  started from subject enrollment to 3 months ± 7 days after the last treatment, up to 5 months

• CTCAE level 4 and 5 toxic reaction ratio is acceptable value

  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)

  the entire clinical trial ( until 3 months after last treatment)

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment

• Duration of Response (DOR)

  screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment

• Disease Control Rate (DCR)

  screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last 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

• 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

Study Arms (1)

Proton radiation therapy group

EXPERIMENTAL

Experimental: single-arm objective performance criteria, OPC

Device: Proton radiation therapy

Interventions

Proton radiation therapy DEVICE

Radiation: Proton Therapy System (ProBeam)

Proton radiation therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ age≤ 80 years;
• First-diagnosed patients with tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs, etc. by tissue/cell pathology;
• ECOG physical condition is graded as 0 to 2;
• Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment;
• 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

You may not qualify if:

• 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;
• 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;
• Implanted pacemakers or other metal prosthesis within the scope of proton therapy;
• Other situations that investigator determines not suitable for enrollment

Sponsors & Collaborators

• Guangzhou Concord Cancer Center: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Varian, a Siemens Healthineers Company: collaborator

Study Sites (1)

Varian ProBeam 360

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

Proton Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Yimin Liu, Professor

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY DIRECTOR

• Shen Fu, Professor

  Guangzhou Concord Cancer Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 22, 2023
• Study Start: December 15, 2022
• Primary Completion: July 4, 2023
• Study Completion: July 4, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)