Proton Beam Re-Irradiation in Thoracic Cancers

• ClinicalTrials.gov Identifier: NCT02204761
• Recruitment Status: Completed
• First Posted: July 30, 2014
• Results First Posted: November 20, 2018
• Last Update Posted: November 20, 2018
• Sponsor: University of Washington
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Jing Zeng, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metastatic Malignant Neoplasm in the Lung; Recurrent Disease; Thoracic Neoplasm	Radiation: Proton Beam Radiation Therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Definitive Re-irradiation With Proton Beam Radiotherapy for Patients With Recurrent Thoracic Cancers
• Actual Study Start Date: September 9, 2014
• Actual Primary Completion Date: September 7, 2017
• Actual Study Completion Date: September 7, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment [ Time Frame: 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 :

1. Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment [ Time Frame: 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.
2. Number of Participants With Local Control of Cancer [ Time Frame: 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.
3. Number of Participants Alive [ Time Frame: Up to 3 months post-treatment ]
   Number of participants alive.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Washington

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109

ProCure Proton Therapy Center-Seattle

Seattle, Washington, United States, 98133

Sponsors and Collaborators

University of Washington

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jing Zeng; Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  Study Documents (Full-Text)

Documents provided by Jing Zeng, University of Washington:

Study Protocol and Statistical Analysis Plan  [PDF] May 21, 2015

More Information

• Responsible Party: Jing Zeng, Principal Investigator, University of Washington
• ClinicalTrials.gov Identifier: NCT02204761
• Other Study ID Numbers: 9148; NCI-2014-01468 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 9148 ( Other Identifier: University of Washington ); P30CA015704 ( U.S. NIH Grant/Contract )
• First Posted: July 30, 2014
• Results First Posted: November 20, 2018
• Last Update Posted: November 20, 2018
• Last Verified: November 2018

Additional relevant MeSH terms:

Neoplasms; Thoracic Neoplasms; Neoplasms by Site