P-Cure
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.
Thoracic Cancer
Pancreatic Cancer Non-resectable
Brain Cancer
Head Cancer
Neck Cancer
Proton Radiation
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 100 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Pivotal Study of Proton Radiotherapy Treatments Using Fixed Beam Chair-Based Delivery System |
Actual Study Start Date : | March 30, 2023 |
Estimated Primary Completion Date : | January 2025 |
Estimated Study Completion Date : | February 2026 |
Arm | Intervention/treatment |
---|---|
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 |
Device: Proton Radiation |
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 |
Device: Proton Radiation |
Experimental: Patients with unresectable pancreatic cancer This prospective study shall evaluate treatment feasibility utilizing the CBGS for unresectable pancreatic cancer with concurrent chemotherapy |
Device: Proton Radiation |
Ages Eligible for Study: | 18 Years to 90 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Accident Karma
Jerusalem, Israel,