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

Launched by P-CURE · Sep 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver proton therapy, which is a type of radiation treatment that targets cancer more precisely than traditional methods. The trial uses a special chair-based system to treat patients with different types of cancer, including thoracic cancer that has come back after previous treatment, head and neck cancer, brain tumors, and pancreatic cancer that cannot be surgically removed. The main goals of the study are to see how well this new system works in controlling the cancer after three months and to compare its effectiveness and safety to standard radiation therapy.

To participate in the trial, patients need to have a confirmed diagnosis of cancer and be eligible for radiation treatment. They should have a life expectancy of more than six months and measurable tumors that are at least 10 millimeters in size. Patients can still join even if they have had other treatments, like chemotherapy or surgery, in the past. However, individuals with certain serious health conditions, those who are pregnant or can become pregnant, or those involved in other clinical trials cannot participate. If you or a loved one is interested in this study, it could offer an opportunity to receive innovative treatment while contributing to important research.

Gender

ALL

Eligibility 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