Thoracic CancerPPTSNCT05549414
Pivotal Study of Proton Radiotherapy Treatments Using Fixed Beam Chair-Based Delivery System
A study testing Proton Radiation in people with Thoracic Cancer and Pancreatic Cancer Non-resectable, run by P-Cure at 1 site in Israel.
Trial summary
This study with Chair-Based, Gantry-less Proton System (CBGS) (aka P-CURE Proton Beam Therapy System or Fixed Beam Chair-based Delivery System) is composed of 3 arms, as following: ARM1: Patients with locally recurrent, previously irradiated thoracic cancer indicated for re- irradiation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Thoracic Cancer, Pancreatic Cancer Non-resectable, Brain Cancer
- What is being tested?
- Proton Radiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Mar 2023to Feb 2026
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically (histologically or cytologically) proven malignancy
- Treatment planning analysis shows advantage to proton over photon treatments
- both malignancies (such as thoracic tumors) as well as metastatic lesions (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed
- Patient must have CT confirmation of the tumor
- Patients must have a life expectancy of > 6 months
- Patients must have measurable disease to be treated with proton radiation (minimum tumor dimension at least 10 mm on CT imaging).
- Patients must be a candidate for definitive radiation dose
- There are no limits on prior therapy. Patients are allowed to have prior chemotherapy and surgery. Patients are allowed to have concurrent chemotherapy with radiation treatment. Patients are allowed to have chemotherapy or surgery after radiation treatment
Who cannot join
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness other than the diagnosed lung cancer requiring hospitalization or precluding study therapy within 30 days before registration
- Acquired immune deficiency syndrome (AIDS) based upon current CDC definition (protocol may be significantly immunosuppressive endangering AIDS patients)
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- Patients with life expectancy < 6 months
- Patients that participate in another, active clinical trial carried out concurrently with this protocol
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Ein Karem
Jerusalem
Irena Barsky, 0534304994, IRAB@hadassah.org.il
About this study
This study with Chair-Based, Gantry-less Proton System (CBGS) (aka P-CURE Proton Beam Therapy System or Fixed Beam Chair-based Delivery System) is composed of 3 arms, as following:
ARM1: Patients with locally recurrent, previously irradiated thoracic cancer indicated for re- irradiation.
Read more
ARM2: Patients with recurrent Head and Neck, Brain and Spinal Cord tumors, indicated for re- irradiation.
ARM3: Patients with unresectable pancreatic cancer.
The primary objectives of the study for all arms are: 1. to describe the efficacy (local control after 3 month) and acute toxicity for patients treated with a fully-integrated CBGS and (2) to compare treatment plans between the fully-integrated CBGS and Photon therapy defined for each patient, based upon OAR sparing for comparable target coverage.
- Being tested
- Proton Radiation
- Medical subject headings
- Brain Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton RadiationDevice
Also called p-cure PROTON RADIATION SYSTEM, Proton Beam Radiation Therapy, Quality-of-Life Assessment
Proton beam radiotherapy, first proposed by Robert Wilson at Harvard University in 1946, utilizes an energetic beam of ionized hydrogen nuclei (protons) directed at the tumor volume to effect DNA damage of the targeted cells. Today, there are hundreds of proton treatment centers worldwide and it is considered standard treatment for certain malignancies and/or clinical scenarios
| Study group | Role | What they receive |
|---|---|---|
| Patients with locally recurrent, previously irradiated thoracic cancer | Experimental | Prospective study shall evaluate treatment efficacy, toxicity, QOL and plan parity in patients with recurrent thoracic cancer previously irradiated, undergoing proton radiation therapy Receives: Device: Proton Radiation |
| Patients with recurrent Head and Neck, Brain and Spinal Cord tumors, indicated for re- irradiation | Experimental | The prospective study shall evaluate treatment Efficacy, Toxicity, Quality of Life (QOL), and plan parity in adult patients with recurrent Head and Neck and Brain cancer undergoing proton radiation therapy Receives: Device: Proton Radiation |
| Patients with unresectable pancreatic cancer | Experimental | This prospective study shall evaluate treatment feasibility utilizing the CBGS for unresectable pancreatic cancer with concurrent chemotherapy Receives: Device: Proton Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control
The duration of local control will be measured from the start date of protocol radiation until the date of progressive disease. Local control will be determined based on RECIST Criteria Version 1.1.
Measured: 3 months
Acute Toxicity
Incidence of treatment-related grade 3-5 adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Measured: 3 months
Treatment Plan Comparison between Chair Based Proton System and Photon therapy
Analysis and comparison of dose volume histograms (DVHs) and isodoses for each modality
Measured: 3 months
Secondary outcomes (4)
Progression Free Survival
The time from study registration until the first occurrence of local, regional, or distant progression, or death from any cause, or until last follow-up
Measured: 2 years
Overall Survival
The time from study registration until death or last follow-up
Measured: 2 years
Long-term Toxicity
Incidence of treatment-related grade 3-5 adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Measured: 2 Years
Quality of Life
Lung Cancer Patients: FACT-Lung and EQ-5D Head and Neck Patients: EORTC QLQ-C30 and the EORTC QLQ-H\&N35 Pancreas Patients: Quality of Life assessment using Patient Reported Outcomes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start30 Mar 2023
- Primary completionJan 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- P-Cure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549414
- Sponsor's protocol ID
- PC001
- Acronym
- PPTS
- Status last verified
- Mar 2023
- First submitted
- 31 Aug 2022
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study of Proton Radiotherapy Treatments Using Fixed Beam Chair-Based Delivery System
- ClinicalTrials.gov ID
- NCT05549414
- Acronym / sponsor ID
- PPTS / PC001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- P-CureIndustry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 22 Sep 2022 (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.
This study with Chair-Based, Gantry-less Proton System (CBGS) (aka P-CURE Proton Beam Therapy System or Fixed Beam Chair-based Delivery System) is composed of 3 arms, as following:
ARM1: Patients with locally recurrent, previously irradiated thoracic cancer indicated for re- irradiation.
ARM2: Patients with recurrent Head and Neck, Brain and Spinal Cord tumors, indicated for re- irradiation.
ARM3: Patients with unresectable pancreatic cancer.
The primary objectives of the study for all arms are: 1. to describe the efficacy (local control after 3 month) and acute toxicity for patients treated with a fully-integrated CBGS and (2) to compare treatment plans between the fully-integrated CBGS and Photon therapy defined for each patient, based upon OAR sparing for comparable target coverage.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with locally recurrent, previously irradiated thoracic cancer | Experimental | Device: Proton RadiationProspective study shall evaluate treatment efficacy, toxicity, QOL and plan parity in patients with recurrent thoracic cancer previously irradiated, undergoing proton radiation therapy |
| Patients with recurrent Head and Neck, Brain and Spinal Cord tumors, indicated for re- irradiation | Experimental | Device: Proton RadiationThe prospective study shall evaluate treatment Efficacy, Toxicity, Quality of Life (QOL), and plan parity in adult patients with recurrent Head and Neck and Brain cancer undergoing proton radiation therapy |
| Patients with unresectable pancreatic cancer | Experimental | Device: Proton RadiationThis prospective study shall evaluate treatment feasibility utilizing the CBGS for unresectable pancreatic cancer with concurrent chemotherapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically (histologically or cytologically) proven malignancy
- Treatment planning analysis shows advantage to proton over photon treatments
- both malignancies (such as thoracic tumors) as well as metastatic lesions (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed
- Patient must have CT confirmation of the tumor
- Patients must have a life expectancy of > 6 months
Key exclusion criteria (8 listed)
- Severe, active co-morbidity, defined as follows:
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- Patients with life expectancy < 6 months
- Patients that participate in another, active clinical trial carried out concurrently with this protocol
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 RadiationAlso: p-cure PROTON RADIATION SYSTEM, Proton Beam Radiation Therapy, Quality-of-Life AssessmentProton beam radiotherapy, first proposed by Robert Wilson at Harvard University in 1946, utilizes an energetic beam of ionized hydrogen nuclei (protons) directed at the tumor volume to effect DNA damage of the targeted cells. Today, there are hundreds of proton treatment centers worldwide and it is considered standard treatment for certain malignancies and/or clinical scenarios | Device | Patients with locally recurrent, previously irradiated thoracic cancer, Patients with recurrent Head and Neck, Brain and Spinal Cord tumors, indicated for re- irradiation, Patients with unresectable pancreatic cancer |
Primary outcome
Local Control
Time frame: 3 months
The duration of local control will be measured from the start date of protocol radiation until the date of progressive disease. Local control will be determined based on RECIST Criteria Version 1.1.
Acute Toxicity
Time frame: 3 months
Incidence of treatment-related grade 3-5 adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Treatment Plan Comparison between Chair Based Proton System and Photon therapy
Time frame: 3 months
Analysis and comparison of dose volume histograms (DVHs) and isodoses for each modality
4 secondary outcomes
Progression Free Survival
Time frame: 2 years
Overall Survival
Time frame: 2 years
Long-term Toxicity
Time frame: 2 Years
Quality of Life
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No
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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.
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 in people with Thoracic Cancer and Pancreatic Cancer Non-resectable, run by P-Cure at 1 site in Israel.
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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Jul 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irena Barsky (0534304994, irab@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control (time frame: 3 months). 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?
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 10 Jul 2023.