Proton radiotherapy using a chair-based delivery system for various cancers
Pivotal Study of Proton Radiotherapy Treatments Using Fixed Beam Chair-Based Delivery System
NA · P-Cure · NCT05549414
This study is testing a new chair-based proton therapy for patients with tough cancers like thoracic, head and neck, brain, spinal cord, and pancreatic cancers to see if it works better and causes less harm to healthy tissue than regular radiation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | P-Cure (industry) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT05549414 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a chair-based proton radiotherapy system for patients with thoracic cancer, recurrent head and neck, brain, and spinal cord tumors, as well as unresectable pancreatic cancer. The study consists of three arms, each targeting different cancer types and assessing local control and acute toxicity after treatment. Patients will receive proton radiation therapy, and treatment plans will be compared to traditional photon therapy to determine advantages in sparing surrounding healthy tissue. The trial aims to provide insights into the efficacy of this innovative delivery system for patients with challenging malignancies.
Who should consider this trial
Good fit: Ideal candidates include patients with locally recurrent thoracic cancer, recurrent head and neck or brain tumors, or unresectable pancreatic cancer who are eligible for proton radiation therapy.
Not a fit: Patients with severe, active co-morbidities or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve local control of tumors while minimizing damage to surrounding healthy tissues.
How similar studies have performed: While proton therapy has been studied previously, this specific chair-based delivery system represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full 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
Where this trial is running
Jerusalem
- Hadassah Ein Karem — Jerusalem, Israel (RECRUITING)
Study contacts
- Study coordinator: Irena Barsky
- Email: irab@hadassah.org.il
- Phone: 0534304994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thoracic Cancer, Pancreatic Cancer Non-resectable, Brain Cancer, Head Cancer, Neck Cancer