- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05313191
Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors (ReRT)
The goal of this clinical research trial is to study the use of differing investigational doses and scheduling for Proton Therapy for tumors previously treated with radiation therapy. Generally, when patients are first treated for cancer with radiation therapy, they are treated with traditional photon (or x-ray) radiation therapy, which uses high-energy waves to kill tumor cells. In some cases, the cancer either returns or a new tumor can present in a different part of the body. With the usual radiation treatment, the photon beams travel all the way through the body. As a result, healthy tissues in front of and behind the tumor are exposed to radiation. Physicians who treat these cases where the tumor has returned often use a much lower dose of radiation to prevent patients from experiencing serious and long-term side-effects. This dose is often not strong enough to destroy the cancerous tumor. Alternatively, they may also treat a smaller area than would be indicated for complete tumor eradication, again in an attempt to prevent serious and long-term toxicities, but at the cost of optimally treating the cancer. Proton therapy, however, may offer a chance to safely deliver a more effective dose and volume of radiation as it is more targeted and can spare healthy tissues surrounding the tumor.
The reason we are conducting this research study is to look at whether Proton therapy can be a better way to treat reoccurring tumors in patients who have previously received radiation therapy to the same area, compared to treatment approaches used to date.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ryan Holder, BS
- Phone Number: 387 646-968-9055
- Email: research@nyproton.com
Study Locations
-
-
New York
-
New York, New York, United States, 10035
- Recruiting
- The New York Proton Center
-
Contact:
- Isabelle Choi, MD
- Phone Number: 646-968-9060
- Email: research@nyproton.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years
- Patient provides study specific informed consent prior to study entry.
- Documented history and physical exam within 90 days prior to registration.
- ECOG PS 0, 1, or 2 within 90 days prior to registration
Exclusion Criteria:
- Non malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up.
Prior invasive non study malignancy unless disease free for ≥ 3 years
- Non melanoma skin cancer, low risk prostate cancer, well differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible.
- History of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1: Central Nervous System
Group 1 Definitive Reirradiation Phase II
Group 2 CNS Reirradiation Registry
|
Use of Pencil Beam Scanning Proton Therapy compared with historical outcomes using photon therapy for the reirradiation of recurrent or new primary malignancies
|
Experimental: Cohort 2: Head/Neck
Group 1 Full Dose Reirradiation Phase II
Group 2 Early (<6months for prior RT) Palliative H/N ReRT Phase I
Group 3 Head/Neck ReRT Registry
|
Use of Pencil Beam Scanning Proton Therapy compared with historical outcomes using photon therapy for the reirradiation of recurrent or new primary malignancies
|
Experimental: Cohort 3: Breast
Group 1 Partial Breast Reirradiation (Phase II)
Group 2: Regional LN and Breast/CW ReRT (Phase II)
Group 3: Breast Reirradiation Registry
|
Use of Pencil Beam Scanning Proton Therapy compared with historical outcomes using photon therapy for the reirradiation of recurrent or new primary malignancies
|
Experimental: Cohort 4: Thoracic
Group 1: Definitive Reirradiation for Locally Advanced Disease
Group 2: Thoracic Registry Study
|
Use of Pencil Beam Scanning Proton Therapy compared with historical outcomes using photon therapy for the reirradiation of recurrent or new primary malignancies
|
Experimental: Cohort 5: Gastrointestinal
Group 1 Esophagus & GEJ Reirradiation Phase II
Group 2 Liver Reirradiation Phase II
Group 3 Lower GI Reirradiation Phase II
Group 4 GI Reirradiation Registry •Patients w/histologically document recurrent or new GI malignancy with prior history of RT w/overlap of current RT volume by the 50% IDL |
Use of Pencil Beam Scanning Proton Therapy compared with historical outcomes using photon therapy for the reirradiation of recurrent or new primary malignancies
|
Experimental: Cohort 6: Genitourinary
Group 1 Locally recurrent prostate cancer w/in prev. radiation field Phase II
Group 2 Regional prostate cancer recurrence adjacent to the previous field Phase II
Group 3 Prostate Reirradiation Registry
|
Use of Pencil Beam Scanning Proton Therapy compared with historical outcomes using photon therapy for the reirradiation of recurrent or new primary malignancies
|
Experimental: Cohort 7: Gynecological
Group 1: Locally recurrent gynecological cancer within previous field
|
Use of Pencil Beam Scanning Proton Therapy compared with historical outcomes using photon therapy for the reirradiation of recurrent or new primary malignancies
|
No Intervention: Cohort 8: Registry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the cumulative rate of CTCAE v5.0 Grade ≥3 acute and late treatment related adverse events within 1 year of definitive reirradiation completion using proton therapy for recurrent or second primary tumor.
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the 1 year freedom from local failure.
Time Frame: 1 year
|
1 year
|
To determine the 1 year freedom from progression free survival.
Time Frame: 1 year
|
1 year
|
To determine the 1 year freedom from overall survival.
Time Frame: 1 year
|
1 year
|
To determine the acute cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 90 days of reirradiation completion.
Time Frame: 90 days
|
90 days
|
To determine the late cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 2 years of reirradiation completion.
Time Frame: 2 years
|
2 years
|
To characterize patient reported outcomes within 1 year of reirradiation using the MDASI BT forms for intracranial tumors.
Time Frame: 1 years
|
1 years
|
To characterize patient reported outcomes within 1 year of reirradiation using the CTB COMP forms for intracranial tumors.
Time Frame: 1 years
|
1 years
|
To characterize patient reported outcomes within 1 year of reirradiation using the MDASI SP form for spinal tumors.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NYPC ERC# 2019-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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