Proton Beam Re-Irradiation in Thoracic Cancers

Completed · Not applicable

Conditions studied: Metastatic Malignant Neoplasm in the Lung, Recurrent Disease, Thoracic Neoplasm

In brief

This pilot clinical trial studies proton beam radiation therapy in treating patients with thoracic cancer that has come back and have received prior radiation therapy. Proton beam radiation therapy uses high energy protons to kill tumor cells and may cause less damage to normal tissue.

Key facts

Study ID

NCT02204761

Run by

University of Washington

People needed

6

Starts

2014-09-09

Expected to finish

2017-09-07

Last updated by the study team

2018-11-20

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Women of child-bearing age must have a negative pregnancy test
• Patients must have received prior radiation treatment to the chest; records of prior radiation treatment must be available
• Patients must have received prior chest radiation at least 3 months prior to enrollment in this trial; radiation treatment to other body sites not overlapping with current radiation fields are allowed within the 3 months period (example, brain radiation is allowed)
• Patients must have a prior diagnosis of cancer inside the thoracic cavity; both primary thoracic malignancies (such as lung cancer) as well as metastatic lesions (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed; patient must have pathologic confirmation of the recurrent thoracic tumor, or have an enlarging thoracic mass (as seen on two computed tomography [CT] scans at least 6 weeks apart, with either a > 25% or > 5 mm increase in longest dimension)
• Patients must have a life expectancy of > 6 months
• Patients must have measurable disease to be treated with proton radiation (minimum tumor dimension at least 10 mm on CT imaging)
• Patients should have either non-metastatic cancer of the thorax, or metastatic cancer to the thorax and candidate for definitive radiation dose to the thoracic tumor (not palliative intent), tumor radiation dose to at least BED2Gy 60 Gy
• Patients must be able to receive proton radiation treatment
• All stages of cancer are eligible
• There are no limits on prior therapy; patients are allowed to have prior chemotherapy and surgery; patients are allowed to have concurrent chemotherapy with radiation treatment; patients are allowed to have chemotherapy or surgery after radiation treatment
• Patients are allowed to be on another study concurrent with this protocol
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• Patients who have never received radiation to the chest
• Patients who received radiation to the chest within the past 3 months (in a region that overlaps with current radiation fields)
• Patients with life expectancy < 6 months
• Pregnant women
• Patients unable to provide informed consent
• Prisoners

Where it is running

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States
• ProCure Proton Therapy Center-Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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