Proton Beam Re-Irradiation in Thoracic Cancers

Not Applicable

Completed

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

Interventions: Radiation: Proton Beam Radiation Therapy

Registration Number: NCT02204761

Lead Sponsor: University of Washington

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 6

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Proton Beam Radiation Therapy	Proton beam radiation therapy

Primary Outcome Measures

Name	Time	Method
Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment	Up to 3 months post-treatment	Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment	Up to 3 months post-treatment	Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Grade 2 generally means medical therapy required to intervene due to toxicity.
Number of Participants With Local Control of Cancer	Up to 3 months post-treatment	Number of participants who did not have local failure as defined by: tumor progression per Response Evaluation Criteria in Solid Tumors criteria - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions inside the full dose radiation field.
Number of Participants Alive	Up to 3 months post-treatment	Number of participants alive.

Trial Locations

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