Proton Beam Radiation Therapy in Treating Patients With Recurrent Thoracic Cancer Who Have Received Prior Radiation Therapy
Conditions
Lung Metastases - Recurrent Malignant Mesothelioma - Recurrent Non-small Cell Lung Cancer - Recurrent Small Cell Lung Cancer - Recurrent Thymoma and Thymic Carcinoma
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms - Mesothelioma - Small Cell Lung Carcinoma - Thymoma
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: proton beam radiation therapy
Type: Radiation
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 19 Years
Gender: Both
Criteria: 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
Location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Status: Recruiting
Contact: Jing Zeng - 206-598-4100
Start Date
September 2014
Sponsors
University of Washington
Source
University of Washington
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page