Proton Beam Re-Irradiation in Thoracic Cancers

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Disease; Thoracic Neoplasm; Metastatic Malignant Neoplasm in the Lung
• Intervention / Treatment: Radiation: Proton Beam Radiation Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
    • Seattle, Washington, United States, 98133
      • ProCure Proton Therapy Center-Seattle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Proton beam radiation therapy	Radiation: Proton Beam Radiation Therapy; Undergo proton beam re-irradiation therapy

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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2014
• Primary Completion (Actual): September 7, 2017
• Study Completion (Actual): September 7, 2017

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 18, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Thoracic Neoplasms
• Other Study ID Numbers: 9148 (Other Identifier: University of Washington); P30CA015704 (U.S. NIH Grant/Contract); NCI-2014-01468 (Registry Identifier: CTRP (Clinical Trial Reporting Program))