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Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors

This study is looking at a type of radiation called Pencil Beam Scanning Proton Therapy for tumors that have already been treated with radiation. Sometimes, cancer can come back or a new tumor can appear. Traditional radiation (photon therapy) can expose healthy tissues to radiation because the beams travel all the way through the body. Proton therapy aims to deliver radiation more precisely. This study will compare the results of proton therapy to past results from photon therapy. You may be able to join if you are 18 or older, have certain cancers (like CNS, head and neck, GI, gynecologic, or prostate cancer), and meet other health requirements. The main goal is to see how many serious side effects (Grade ≥3) occur within one year of treatment, with results measured over five years. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 1800 participants. It is comparing Pencil Beam Scanning Proton Therapy to historical outcomes of photon therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 5 years, suggesting participants will be followed for at least that long after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05313191

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

Recruiting
NAAges 18+InterventionalTreatment
The New York Proton Center
~1,800 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Pencil Beam Scanning Proton Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 5 years

Conditions

CNS Cancer
Head and Neck Cancer
GI Cancer
Gynecologic Cancer
Prostate Cancer
Thoracic Cancer
Breast Cancer

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Breast CarcinomaGI CancerMalignant Central Nervous System NeoplasmMalignant Female Reproductive System NeoplasmMalignant Head and Neck NeoplasmProstate CarcinomaSolid NeoplasmThoracic Neoplasm

Where it's being run

1 sites across 1 states
New York1

Who to contact

Ryan Holder, BS
[email protected]
646-968-9055 · ext. 387
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.5 years