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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
Hadassah Ein Karem
Jerusalem, Israel
RECRUITINGLocal Control
The duration of local control will be measured from the start date of protocol radiation until the date of progressive disease. Local control will be determined based on RECIST Criteria Version 1.1.
Time frame: 3 months
Acute Toxicity
Incidence of treatment-related grade 3-5 adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Time frame: 3 months
Treatment Plan Comparison between Chair Based Proton System and Photon therapy
Analysis and comparison of dose volume histograms (DVHs) and isodoses for each modality
Time frame: 3 months
Progression Free Survival
The time from study registration until the first occurrence of local, regional, or distant progression, or death from any cause, or until last follow-up
Time frame: 2 years
Overall Survival
The time from study registration until death or last follow-up
Time frame: 2 years
Long-term Toxicity
Incidence of treatment-related grade 3-5 adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Time frame: 2 Years
Quality of Life
Lung Cancer Patients: FACT-Lung and EQ-5D Head and Neck Patients: EORTC QLQ-C30 and the EORTC QLQ-H\&N35 Pancreas Patients: Quality of Life assessment using Patient Reported Outcomes
Time frame: 2 years
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