Proton Beam Re-Irradiation in Thoracic Cancers

Study Overview
=================
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.

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

Conditions
-----------------
Metastatic Malignant Neoplasm in the Lung, Recurrent Disease, Thoracic Neoplasm

Intervention / Treatment
-----------------
* Radiation: Proton Beam Radiation Therapy


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Proton beam radiation therapy | Radiation: Proton Beam Radiation Therapy<br>* Undergo proton beam re-irradiation therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation 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. | Up to 3 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Grade 2 Toxicity Attributable to Radiation 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. | Up to 3 months post-treatment | 
| Number of Participants With Local Control of Cancer | 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. | Up to 3 months post-treatment | 
| Number of Participants Alive | Number of participants alive. | Up to 3 months post-treatment |