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

Brain Cancer Clinical Trial

— PPTS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05549414
• Other study ID #: PC001
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: February 2026

Study information

• Verified date: March 2023
• Source: P-Cure
• Contact: Irena Barsky
• Phone: 0534304994
• Email: irab[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Ein Karem	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
P-Cure	Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Overall Survival	The time from study registration until death or last follow-up	2 years
Secondary	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
Secondary	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