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

Primary Purpose

Thoracic Cancer, Pancreatic Cancer Non-resectable, Brain Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Proton Radiation

About this trial

This is an interventional treatment trial for Thoracic Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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)
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Patients with life expectancy < 6 months
Patients that participate in another, active clinical trial carried out concurrently with this protocol

Sites / Locations

Hadassah Ein KaremRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Patients with locally recurrent, previously irradiated thoracic cancer

Patients with recurrent Head and Neck, Brain and Spinal Cord tumors, indicated for re- irradiation

Patients with unresectable pancreatic cancer

Arm Description

Prospective study shall evaluate treatment efficacy, toxicity, QOL and plan parity in patients with recurrent thoracic cancer previously irradiated, undergoing proton radiation therapy

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

This prospective study shall evaluate treatment feasibility utilizing the CBGS for unresectable pancreatic cancer with concurrent chemotherapy

Outcomes

Primary Outcome Measures

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.

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

Treatment Plan Comparison between Chair Based Proton System and Photon therapy

Analysis and comparison of dose volume histograms (DVHs) and isodoses for each modality

Secondary Outcome Measures

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

Overall Survival

The time from study registration until death or last follow-up

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

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

Full Information

NCT ID

NCT05549414

First Posted

August 31, 2022

Last Updated

July 6, 2023

Sponsor

P-Cure

Collaborators

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT05549414

Brief Title

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

Acronym

PPTS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 30, 2023 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

P-Cure

Collaborators

Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with locally recurrent, previously irradiated thoracic cancer

Arm Type

Experimental

Arm Description

Prospective study shall evaluate treatment efficacy, toxicity, QOL and plan parity in patients with recurrent thoracic cancer previously irradiated, undergoing proton radiation therapy

Arm Title

Patients with recurrent Head and Neck, Brain and Spinal Cord tumors, indicated for re- irradiation

Arm Type

Experimental

Arm Description

Arm Title

Patients with unresectable pancreatic cancer

Arm Type

Experimental

Arm Description

This prospective study shall evaluate treatment feasibility utilizing the CBGS for unresectable pancreatic cancer with concurrent chemotherapy

Intervention Type

Device

Intervention Name(s)

Proton Radiation

Other Intervention Name(s)

p-cure PROTON RADIATION SYSTEM, Proton Beam Radiation Therapy, Quality-of-Life Assessment

Intervention Description

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

Primary Outcome Measure Information:

Title

Local Control

Description

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

Title

Acute Toxicity

Description

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

Title

Treatment Plan Comparison between Chair Based Proton System and Photon therapy

Description

Analysis and comparison of dose volume histograms (DVHs) and isodoses for each modality

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Progression Free Survival

Description

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

Title

Overall Survival

Description

The time from study registration until death or last follow-up

Time Frame

2 years

Title

Long-term Toxicity

Description

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

Title

Quality of Life

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the last 6 months 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 Acquired immune deficiency syndrome (AIDS) based upon current CDC definition (protocol may be significantly immunosuppressive endangering AIDS patients) Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception Patients with life expectancy < 6 months Patients that participate in another, active clinical trial carried out concurrently with this protocol

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Irena Barsky

Phone

0534304994

irab@hadassah.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Ori Lubin

Phone

0544881399

ori.lubin@p-cure.com

Facility Information:

Facility Name

Hadassah Ein Karem

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Irena Barsky

Phone

0534304994

IRAB@hadassah.org.il

12. IPD Sharing Statement

Plan to Share IPD

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

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