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

Sponsor
P-Cure (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05549414
Collaborator
Hadassah Medical Organization (Other)
100
Enrollment
3
Arms
38
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Proton Radiation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pivotal Study of Proton Radiotherapy Treatments Using Fixed Beam Chair-Based Delivery System
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

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

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Local Control [3 months]

      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.

    2. Acute Toxicity [3 months]

      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. Treatment Plan Comparison between Chair Based Proton System and Photon therapy [3 months]

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

    Secondary Outcome Measures

    1. Progression Free Survival [2 years]

      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. Overall Survival [2 years]

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

    3. Long-term Toxicity [2 Years]

      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

    4. Quality of Life [2 years]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    2. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

    3. Transmural myocardial infarction within the last 6 months

    4. 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

    5. Acquired immune deficiency syndrome (AIDS) based upon current CDC definition (protocol may be significantly immunosuppressive endangering AIDS patients)

    6. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

    7. Patients with life expectancy < 6 months

    8. Patients that participate in another, active clinical trial carried out concurrently with this protocol

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • P-Cure
    • Hadassah Medical Organization

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    P-Cure
    ClinicalTrials.gov Identifier:
    NCT05549414
    Other Study ID Numbers:
    • PC001
    First Posted:
    Sep 22, 2022
    Last Update Posted:
    Sep 22, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Brain Neoplasms

    Study Results

    No Results Posted as of Sep 22, 2022