Skip to main content
OpenTrials
Completed

NCT Number: NCT05914142

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Solid Tumor Proton Therapy Radiation Therapy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Varian ProBeam 360

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Proton Radiation Therapy

Device

Radiation: Proton Therapy System (ProBeam)

Primary outcomes

  1. tumor disease control rate reaches the objective performance criteria

    Time frame: 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.

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

    Time frame: 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

  3. CTCAE level 4 and 5 toxic reaction ratio is acceptable value

    Time frame: 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)

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 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

  2. Duration of Response (DOR)

    Time frame: 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.

  3. Disease Control Rate (DCR)

    Time frame: 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

  4. tumor markers (if applicable), Tumor-specific symptoms

    Time frame: 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)

  5. actual situation of Product usability evaluation (ProBeam system, Oncology Information system (OIS), Treatment plan system (Eclipse))

    Time frame: 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.

  6. CTCAE level 1 and 2 toxic reaction ratio, Adverse Events (AE) rate, Serious Adverse Events (SAE) rate

    Time frame: 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

  7. lab test, Eastern Cooperative Oncology Group (ECOG) grade

    Time frame: 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.

  8. tumor recurrence rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Guangzhou Concord Cancer Center

Other

Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Varian, a Siemens Healthineers Company

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 22, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.