Proton Beam Re-Irradiation in Thoracic Cancers

N/ACompletedNCT02204761

University of Washington6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Malignant Neoplasm in the Lung Recurrent Disease Thoracic Neoplasm

Interventions

Proton Beam Radiation TherapyRADIATION

Undergo proton beam re-irradiation therapy

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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.

Time frame: Up to 3 months post-treatment

Secondary Outcomes

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.

Time frame: 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.

Time frame: Up to 3 months post-treatment

Number of Participants Alive

Number of participants alive.

Time frame: Up to 3 months post-treatment

Data from ClinicalTrials.gov

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