Proton Beam Re-Irradiation in Thoracic Cancers

NCT ID: NCT02204761

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-09
• Study Completion Date: 2017-09-07

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.

Conditions

Metastatic Malignant Neoplasm in the Lung; Recurrent Disease; Thoracic Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Proton beam radiation therapy

Group Type: EXPERIMENTAL

Proton Beam Radiation Therapy

Intervention Type: RADIATION

Undergo proton beam re-irradiation therapy

Interventions

Proton Beam Radiation Therapy

Undergo proton beam re-irradiation therapy

Intervention Type: RADIATION

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jing Zeng

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Zeng

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Locations

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

ProCure Proton Therapy Center-Seattle

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2014-01468

Identifier Type: REGISTRY

Identifier Source: secondary_id

9148

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9148

Identifier Type: -

Identifier Source: org_study_id