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

Обзор

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.

Вмешательства

• Лучевая терапия 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

Первичные конечные точки

• 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. [Срок оценки: 5 years]

Вторичные конечные точки (8)

• To determine the 1 year freedom from local failure. [Срок оценки: 1 year]
• To determine the 1 year freedom from progression free survival. [Срок оценки: 1 year]
• To determine the 1 year freedom from overall survival. [Срок оценки: 1 year]
• To determine the acute cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 90 days of reirradiation completion. [Срок оценки: 90 days]
• To determine the late cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 2 years of reirradiation completion. [Срок оценки: 2 years]
• To characterize patient reported outcomes within 1 year of reirradiation using the MDASI BT forms for intracranial tumors. [Срок оценки: 1 years]
• To characterize patient reported outcomes within 1 year of reirradiation using the CTB COMP forms for intracranial tumors. [Срок оценки: 1 years]
• To characterize patient reported outcomes within 1 year of reirradiation using the MDASI SP form for spinal tumors. [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The New York Proton Center — New York

Идентификаторы

NCT: NCT05313191 · NYPC ERC# 2019-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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