Pivotal Study of Proton Radiotherapy Treatments Using Fixed Beam Chair-Based Delivery System

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

1. Severe, active co-morbidity, defined as follows: 1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months. 2. Transmural myocardial infarction within the last 6 months. 3. 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. 4. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition (protocol may be significantly immunosuppressive endangering AIDS patients) 2. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception. 3. Patients with life expectancy < 6 months. 4. Patients that participate in another, active clinical trial carried out concurrently with this protocol

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05549414
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	P-Cure
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	Israel
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Thoracic Cancer, Pancreatic Cancer Non-resectable, Brain Cancer, Head Cancer, Neck Cancer

Arms & Interventions

Arms

Experimental: Patients with locally recurrent, previously irradiated thoracic cancer

Prospective study shall evaluate treatment efficacy, toxicity, QOL and plan parity in patients with recurrent thoracic cancer previously irradiated, undergoing proton radiation therapy

Experimental: Patients with recurrent Head and Neck, Brain and Spinal Cord tumors, indicated for re- irradiation

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

Experimental: Patients with unresectable pancreatic cancer

This prospective study shall evaluate treatment feasibility utilizing the CBGS for unresectable pancreatic cancer with concurrent chemotherapy

Interventions

Device: - Proton Radiation

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

Contact a Trial Team

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