Solid TumorNCT05914142

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

A study testing Proton radiation therapy in people with Solid Tumor and Radiation Therapy, run by Guangzhou Concord Cancer Center at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Solid Tumor, Radiation Therapy, Proton Therapy
What is being tested?: Proton radiation therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteChina
Study dates: 15 Dec 2022to 4 Jul 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Varian ProBeam 360
Guangzhou, Guangdong, 510000

Other trials in China

About this study

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.

Read the 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.

Conditions: Solid Tumor, Radiation Therapy, Proton Therapy
Being tested: Proton radiation therapy
Keywords: varian, Probeam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Proton radiation therapyDevice
Radiation: Proton Therapy System (ProBeam)

Study groups in NCT05914142
Study group	Role	What they receive
Proton radiation therapy group	Experimental	Experimental: single-arm objective performance criteria, OPC Receives: Device: Proton radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

Objective Response Rate (ORR)
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
Measured: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
Duration of Response (DOR)
The duration of the tumor's first assessment as CR or PR, until the first assessment of PD or death due to any cause.
Measured: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
Disease Control Rate (DCR)
CR, PR, SD for disease control after treatment
Measured: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
tumor markers (if applicable), Tumor-specific symptoms
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)
Measured: 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))
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.
Measured: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
CTCAE level 1 and 2 toxic reaction ratio, Adverse Events (AE) rate, Serious Adverse Events (SAE) rate
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
Measured: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
lab test, Eastern Cooperative Oncology Group (ECOG) grade
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.
Measured: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
tumor recurrence rate
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
Measured: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 20224 Jul 2023

First posted22 Jun 2023
Study start15 Dec 2022
Primary completion4 Jul 2023
Study completion4 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05914142
Sponsor's protocol ID: SYSQX-2022-046-02
Status last verified: Nov 2023
First submitted: 9 May 2023
Last updated: 7 Nov 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on the Safety and Effectiveness of Varian ProBeam Proton Therapy Equipment in the Treatment of Solid Tumors
ClinicalTrials.gov ID: NCT05914142
Acronym / sponsor ID: SYSQX-2022-046-02
Conditions: Solid Tumor, Radiation Therapy, Proton Therapy
Keywords: varian, Probeam
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Guangzhou Concord Cancer CenterUniversity, hospital or other
Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Varian, a Siemens Healthineers Company
Study start: 15 Dec 2022 (actual)
Primary completion: 4 Jul 2023 (actual)
Study completion: 4 Jul 2023 (actual)
First posted: 22 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Proton radiation therapy group	Experimental	Device: Proton radiation therapyExperimental: single-arm objective performance criteria, OPC

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Proton radiation therapyRadiation: Proton Therapy System (ProBeam)	Device	Proton radiation therapy group

Primary outcome

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.
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
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)

8 secondary outcomes

Objective Response Rate (ORR)
Time frame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
Duration of Response (DOR)
Time frame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
Disease Control Rate (DCR)
Time frame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment
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
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
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
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
tumor recurrence rate
Time frame: screening, 1 months ± 7 days, 2 months ± 7 days, 3 months ± 7 days after the last treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
Individual participant dataSharing planned: No

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yimin Liu, Professor study director

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

Shen Fu, Professor study director

Guangzhou Concord Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Proton radiation therapy in people with Solid Tumor and Radiation Therapy, run by Guangzhou Concord Cancer Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tumor disease control rate reaches the objective performance criteria (time frame: 3 months ± 7 days after the last treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05914142.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.