Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pencil Beam Scanning Proton Therapy.
- Who it may be relevant to
- Registry conditions: CNS Cancer, Head and Neck Cancer, GI Cancer, Gynecologic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome 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. [Time frame: 5 years]
Secondary outcome measures (8)
- To determine the 1 year freedom from local failure. [Time frame: 1 year]
- To determine the 1 year freedom from progression free survival. [Time frame: 1 year]
- To determine the 1 year freedom from overall survival. [Time frame: 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]
- 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]
- To characterize patient reported outcomes within 1 year of reirradiation using the MDASI BT forms for intracranial tumors. [Time frame: 1 years]
- To characterize patient reported outcomes within 1 year of reirradiation using the CTB COMP forms for intracranial tumors. [Time frame: 1 years]
- To characterize patient reported outcomes within 1 year of reirradiation using the MDASI SP form for spinal tumors. [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The New York Proton Center — New York
Identifiers
NCT: NCT05313191 · NYPC ERC# 2019-002