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

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 Overview

• Status: Recruiting
• Conditions: Brain Cancer; Thoracic Cancer; Head Cancer; Neck Cancer; Pancreatic Cancer Non-resectable
• Intervention / Treatment: Device: Proton Radiation

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• 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

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Hadassah Ein Karem
    • Contact: Irena Barsky; Phone Number: 0534304994; Email: IRAB@hadassah.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

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 proton treatment centers worldwide and it is considered standard treatment for certain malignancies and/or clinical scenarios; Other Names: Quality-of-Life Assessment; p-cure PROTON RADIATION SYSTEM; Proton Beam Radiation Therapy
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 proton treatment centers worldwide and it is considered standard treatment for certain malignancies and/or clinical scenarios; Other Names: Quality-of-Life Assessment; p-cure PROTON RADIATION SYSTEM; Proton Beam Radiation Therapy
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 proton treatment centers worldwide and it is considered standard treatment for certain malignancies and/or clinical scenarios; Other Names: Quality-of-Life Assessment; p-cure PROTON RADIATION SYSTEM; Proton Beam Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: P-Cure
• Collaborators: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Head and Neck Neoplasms; Brain Neoplasms
• Other Study ID Numbers: PC001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No