Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors (ReRT)

April 6, 2026 updated by: The New York Proton Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10035
        • Recruiting
        • The New York Proton Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1: Central Nervous System

Group 1 Definitive Reirradiation Phase II

  • Patients w/history of intracranial or spinal (extradural, intradural, and/or intramedullary) CNS tumors for which radiation therapy was prev. delivered either to gross disease or in the postoperative setting
  • Min. 6 month interval b/w RT courses
  • Overlap of prior RT field (50% IDL)
  • Subgroup analysis: receipt of surgery for recurrence/second IC tumor; concurrent ST; tumor histology

Group 2 CNS Reirradiation Registry

  • Patients for whom a repeat course of RT to the CNS is indicated for recurrent disease or secondary primary
  • Postop or intact setting
  • Min. 6 month interval b/w RT courses
  • Overlap of prior RT field (50% IDL)
  • Histologically/clinically documented recurrent CNS tumor (benign or malignant)
  • Glioblastoma (histologic or molecular including IDH wildtype)
  • Astrocytoma (molecular IDH1 mutant)
  • Oligodendroglioma (molecular 1p19q co deleted)
  • Meningioma
  • Ependymoma
  • Chordoma/chondrosarcoma
Radiation: Pencil Beam Scanning Proton Therapy
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

  • Patients w/history of HNC for which RT was delivered definitively, now with recurrence to h/n amenable to full dose reRT
  • Gross unresected disease or PORT 2/2 RF
  • Received at least 40 Gy overlapping w/new target region
  • Min. 6 month interval b/w RT courses
  • Overlap of prior RT field (50% IDL)
  • Subgroup analysis: surgery, HPV status, concurrent ST

Group 2 Early (<6months for prior RT) Palliative H/N ReRT Phase I

  • Patients w/history of HNC for which RT was delivered definitively/adjuvant setting, now with biopsy proven recurrence to h/n with indication for palliative RT
  • At least 30 Gy prior RT overlapping with new treatment volume
  • <6 month interval between RT courses

Group 3 Head/Neck ReRT Registry

  • Patients w/history of HNC for which RT was delivered now with recurrence/secondary primary requiring reRT
  • Postop or definitive
  • Prior RT dose at least 30 Gy overlapping w/new treatment volume
  • Min.6 month interval b/w RT courses
Radiation: Pencil Beam Scanning Proton Therapy
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)

  • Patients with a history of breast cancer s/p BCT, now with small (≤3cm), unicentric, ipsilateral breast cancer recurrence receiving repeat BCT
  • Node negative
  • Negative margins
  • No LVI
  • Lumpectomy cavity:whole breast <30%
  • Minimum 1 year interval between RT courses

Group 2: Regional LN and Breast/CW ReRT (Phase II)

  • Patients with a history of breast cancer s/p RT , now with recurrence or new primary with indication for reirradiation to the breast/chest wall and regional LN
  • Minimum 1 year interval between RT courses
  • Negative metastatic workup (PET/CT or CT C/A/P + bone scan)
  • Excludes concurrent chemotherapy

Group 3: Breast Reirradiation Registry

  • Patients with a history of breast cancer s/p RT , now with recurrence or new primary breast cancer with indication for reirradiation
  • Some overlaps of dose with prior RT course
  • Negative metastatic workup (PET/CT or CT C/A/P + bone scan)
  • Excludes concurrent chemotherapy
Radiation: Pencil Beam Scanning Proton Therapy
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

  • Single arm, prospective, phase II study
  • Patients with a history of lung cancer s/p definitive RT , now with local recurrence of new primary centrally located and w/I 50% IDL of prior RT field
  • Definitive reRT concurrent systemic therapy
  • Adequate pulmonary function defined as an FEV1 of >35% (with or without bronchodilator) within 90 days prior to registration
  • Minimum 6 month interval between RT courses
  • Negative metastatic workup

Group 2: Thoracic Registry Study

  • Registry design
  • Patients with histologically confirmed thoracic malignancy (NSCLC, SCLC , mesothelioma, thymoma, carcinoid, intrathoracic sarcoma) with prior thoracic RT
  • Minimum 3 month interval between RT courses
  • Negative metastatic workup
Radiation: Pencil Beam Scanning Proton Therapy
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

  • Patients w/history of E/GEJ cancer s/p RT, now w/recurrent/new primary nonmetastatic E/GEJ cancer for which salvage RT is recommended
  • Negative metastatic workup

Group 2 Liver Reirradiation Phase II

  • Patients w/history of HCC, cholangiocarcinoma or liver mets (any histology), s/p prior EBRT, now with in field recurrence/new primary/met, for which definitive reRT is recommended
  • CTP A or B7
  • Excl. prev. Y 90/radioembolization
  • Allow prior TACE
  • Overlap w/50% IDL prior RT
  • Adequate bone marrow function

Group 3 Lower GI Reirradiation Phase II

  • Patients w/history of rectal/anal cancer s/p RT now w/recurrent/new primary nonmetastatic rectal/anal cancer for whom salvage RT is recommended +/ chemotherapy
  • Negative metastatic workup (PET/CT or CT C/A/P)

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
Radiation: Pencil Beam Scanning Proton Therapy
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

  • Patients w/recurrent prostate adenocarcinoma w/in prev. irradiated field w/indication for repeat course of radiation
  • Min. 1 year interval b/w RT courses
  • Prostate gland or recurrent tumor <100 cc or 6 cm in largest dimension
  • No persistent grade 2+ toxicity from prior radiation
  • Negative metastatic workup (bone scan, CT scan or PSMA/axumin scan

Group 2 Regional prostate cancer recurrence adjacent to the previous field Phase II

  • Patients w/recurrent prostate adenocarcinoma beyond prior RT field (outside 50% IDL) but w/in pelvis)
  • Min.1 year interval b/w RT courses (EBRT or brachy)
  • No persistent grade 2+ toxicity from prior radiation

Group 3 Prostate Reirradiation Registry

  • Patients w/recurrent prostate adenocarcinoma (prostate gland, postop bed, or pelvi c LN) who require RT to the prostate or pelvis in the setting of prior pelvis RT
  • No DM
  • Concurrent chemotherapy excl.
Radiation: Pencil Beam Scanning Proton Therapy
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

  • Single arm, prospective, phase II study design
  • Patients with history of gyn cancer for which definitive or adjuvant/salvage PORT was given, now with recurrence within 50% IDL recommended for radiotherapy
  • At least 1 year between RT courses
  • No persistent grade 3+ toxicity from prior RT
  • Concurrent chemotherapy excluded
  • Uncontrolled or widely metastatic disease
  • Life expectancy >6 months
Radiation: Pencil Beam Scanning Proton Therapy
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
  • Registry design
  • Any cancer patient for whom RT is indicated in the setting of prior RT and do not meet eligibility criteria for other cohorts
  • Overlap of 50% IDL of current treatment volume with prior RT field

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The New York Proton Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NYPC ERC# 2019-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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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