NCT05549414

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: P-Cure · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Thoracic Cancer
• Pancreatic Cancer Non-resectable
• Brain Cancer
• Head Cancer
• Neck Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-30
• Primary completion: 2025-01-01
• Completion: 2026-02-01
• First posted: 2022-09-22
• Last updated: 2023-07-10

Locations

1 site across 1 country: Israel