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Proton Beam Re-Irradiation in Thoracic Cancers | Clinical Trials | Clareo Health

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Proton Beam Re-Irradiation in Thoracic Cancers

Definitive Re-irradiation With Proton Beam Radiotherapy for Patients With Recurrent Thoracic Cancers

NCT02204761•University of Washington

Summary

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.

Detailed Description

PRIMARY OBJECTIVES: I. To assess the grade 3 toxicity associated with thoracic re-irradiation with proton therapy, with prospectively applied normal organ radiation dose limits. SECONDARY OBJECTIVES: I. To assess the efficacy of thoracic re-irradiation with proton therapy. OUTLINE: Patients undergo proton beam radiation therapy per standard of care. After completion of study treatment, patients are followed up at 3 months.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+2 more criteria

Exclusion Criteria

•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

Locations (2)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

ProCure Proton Therapy Center-Seattle

Seattle, Washington, United States

Key Dates

Start Date

September 9, 2014

Primary Completion Date

September 7, 2017

Completion Date

September 7, 2017

Last Updated

November 20, 2018

Enrollment

ACTUAL participants

Conditions

Metastatic Malignant Neoplasm in the LungRecurrent DiseaseThoracic Neoplasm

Interventions

Proton Beam Radiation Therapy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Proton Beam Re-Irradiation in Thoracic Cancers

Inclusion Criteria

Exclusion Criteria

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