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| Name | Class |
|---|---|
| Hadassah Medical Organization | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Patients with unresectable pancreatic cancer | Experimental | This prospective study shall evaluate treatment feasibility utilizing the CBGS for unresectable pancreatic cancer with concurrent chemotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Radiation | Device | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Severe, active co-morbidity, defined as follows:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irena Barsky | Contact | 0534304994 | irab@hadassah.org.il | |
| Ori Lubin | Contact | 0544881399 | ori.lubin@p-cure.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Ein Karem | Recruiting | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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|
|
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 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |