Proton Beam Re-Irradiation in Thoracic Cancers

NCT02204761 | Completed Results

• 3 other identifiers: 9148NCI-2014-01468P30CA015704
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment

  Up to 3 months post-treatment

• Number of Participants With Local Control of Cancer

  Up to 3 months post-treatment

• Number of Participants Alive

  Up to 3 months post-treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Proton beam radiation therapy

Radiation: Proton Beam Radiation Therapy

Interventions

Proton Beam Radiation Therapy RADIATION

Undergo proton beam re-irradiation therapy

Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

ProCure Proton Therapy Center-Seattle

Seattle, Washington, 98133, United States

Location

MeSH Terms

Conditions

Recurrence; Thoracic Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Dr. Jing Zeng
• Organization: University of Washington Medical Center

jzeng13@uw.edu

2065984110

Study Officials

• Jing Zeng

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: September 9, 2014
• Primary Completion: September 7, 2017
• Study Completion: September 7, 2017
• Last Updated: November 20, 2018
• Results First Posted: November 20, 2018

Record last verified: 2018-11

Locations

US (2)