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

Study Overview

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

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.

N/A

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

DEVICE: Proton Radiation

PC001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-08-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-07-06
First Submitted that Met QC Criteria 2022-09-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-07-10
First Posted (ACTUAL) 2022-09-22	Results First Posted N/A	Last Verified 2023-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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 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
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 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
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 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

Participant Group/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

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

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

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

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

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

Primary Outcome Measures	Measure Description	Time Frame
Local 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.	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	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	3 months

Secondary Outcome Measures	Measure Description	Time Frame
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	2 years
Overall Survival	The time from study registration until death or last follow-up	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	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	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Irena Barsky

Phone Number: 0534304994

Email: irab@hadassah.org.il

Study Contact Backup

Name: Ori Lubin

Phone Number: 0544881399

Email: ori.lubin@p-cure.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Hadassah Medical Organization

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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