Clinical trial NCT05313191: Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors
Official title: Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CNS Cancer
Head and Neck Cancer
GI Cancer
Gynecologic Cancer
Prostate Cancer
Thoracic Cancer
Breast Cancer
Keywords: Reirradiation
Cancer
Proton Therapy
Radiation Therapy
Lead sponsor: The New York Proton Center
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Phase: Registry, Phase I, Phase II Study Design/Methodology: Cohort-defined, single arm prospective study
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: 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.
timeFrame: 5 years
Secondary outcomes:
measure: To determine the 1 year freedom from local failure.
timeFrame: 1 year
measure: To determine the 1 year freedom from progression free survival.
timeFrame: 1 year
measure: To determine the 1 year freedom from overall survival.
timeFrame: 1 year
measure: To determine the acute cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 90 days of reirradiation completion.
timeFrame: 90 days
measure: To determine the late cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 2 years of reirradiation completion.
timeFrame: 2 years
measure: To characterize patient reported outcomes within 1 year of reirradiation using the MDASI BT forms for intracranial tumors.
timeFrame: 1 years
measure: To characterize patient reported outcomes within 1 year of reirradiation using the CTB COMP forms for intracranial tumors.
timeFrame: 1 years
measure: To characterize patient reported outcomes within 1 year of reirradiation using the MDASI SP form for spinal tumors.
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Proton Center
state: New York
Study officials:
References: