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Proton Beam Re-Irradiation in Thoracic Cancers

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton Beam Radiation Therapy
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Malignant Neoplasm in the Lung

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  • ProCure Proton Therapy Center-Seattle

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Proton beam radiation therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Number of Participants Alive
Number of participants alive.

Full Information

First Posted
July 28, 2014
Last Updated
November 18, 2018
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02204761
Brief Title
Proton Beam Re-Irradiation in Thoracic Cancers
Official Title
Definitive Re-irradiation With Proton Beam Radiotherapy for Patients With Recurrent Thoracic Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 9, 2014 (Actual)
Primary Completion Date
September 7, 2017 (Actual)
Study Completion Date
September 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Malignant Neoplasm in the Lung, Recurrent Disease, Thoracic Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Proton beam radiation therapy
Intervention Type
Radiation
Intervention Name(s)
Proton Beam Radiation Therapy
Intervention Description
Undergo proton beam re-irradiation therapy
Primary Outcome Measure Information:
Title
Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment
Description
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 Outcome Measure Information:
Title
Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment
Description
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
Title
Number of Participants With Local Control of Cancer
Description
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
Title
Number of Participants Alive
Description
Number of participants alive.
Time Frame
Up to 3 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Zeng
Organizational Affiliation
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
ProCure Proton Therapy Center-Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States

12. IPD Sharing Statement

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Proton Beam Re-Irradiation in Thoracic Cancers

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