To hear about similar clinical trials, please enter your email below
Trial Title:
Pivotal Study of Proton Radiotherapy Treatments Using Fixed Beam Chair-Based Delivery System
NCT ID:
NCT05549414
Condition:
Thoracic Cancer
Pancreatic Cancer Non-resectable
Brain Cancer
Head Cancer
Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Brain Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Proton Radiation
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
Arm group label:
Patients with locally recurrent, previously irradiated thoracic cancer
Arm group label:
Patients with recurrent Head and Neck, Brain and Spinal Cord tumors, indicated for re- irradiation
Arm group label:
Patients with unresectable pancreatic cancer
Other name:
p-cure PROTON RADIATION SYSTEM
Other name:
Proton Beam Radiation Therapy
Other name:
Quality-of-Life Assessment
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.
Criteria for 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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hadassah Ein Karem
Address:
City:
Jerusalem
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Irena Barsky
Phone:
0534304994
Email:
IRAB@hadassah.org.il
Start date:
March 30, 2023
Completion date:
February 2026
Lead sponsor:
Agency:
P-Cure
Agency class:
Industry
Collaborator:
Agency:
Hadassah Medical Organization
Agency class:
Other
Source:
P-Cure
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05549414
