Proton Beam Re-Irradiation in Thoracic Cancers

University of Washington

Status

Completed

Conditions

Recurrent Disease

Thoracic Neoplasm

Metastatic Malignant Neoplasm in the Lung

Treatments

Radiation: Proton Beam Radiation Therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02204761

9148 (Other Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

NCI-2014-01468 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

19+ years old

Volunteers

No 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
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

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