NCT05313191Recruiting
Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1800 (estimated)
- First submitted
- 21 Mar 2022
- Start date
- 24 Jan 2022
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- The New York Proton Center
- Diseases
- Prostate cancer, Head and neck cancer
- NCT number
- NCT05313191
What you commit to
- Study type: Interventional
- Planned participants: 1800
- From 24 Jan 2022 to the primary completion date, 31 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Non malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up.
Other illness
- History of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum
Age
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The New York Proton Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.