NCT05549414

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

July 10, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

August 31, 2022

Last Update Submit

July 6, 2023

Conditions

Thoracic CancerPancreatic Cancer Non-resectableBrain CancerHead CancerNeck Cancer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Progression Free Survival

    2 years

  • Overall Survival

    2 years

  • Long-term Toxicity

    2 Years

  • Quality of Life

    2 years

Study Arms (3)

Patients with locally recurrent, previously irradiated thoracic cancer

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Patients with unresectable pancreatic cancer

EXPERIMENTAL

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

Device: Proton Radiation

Interventions

Proton RadiationDEVICE

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

Also known as: p-cure PROTON RADIATION SYSTEM, Proton Beam Radiation Therapy, Quality-of-Life Assessment
Patients with locally recurrent, previously irradiated thoracic cancerPatients with recurrent Head and Neck, Brain and Spinal Cord tumors, indicated for re- irradiationPatients with unresectable pancreatic cancer

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Ein Karem

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Brain NeoplasmsHead and Neck Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Central Study Contacts

Irena Barsky

CONTACT

0534304994irab@hadassah.org.il

Ori Lubin

CONTACT

0544881399ori.lubin@p-cure.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 22, 2022

Study Start

March 30, 2023

Primary Completion

January 1, 2025

Study Completion

February 1, 2026

Last Updated

July 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)