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Proton Beam Re-Irradiation in Thoracic Cancers

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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:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jing Zeng, University of Washington

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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

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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204761


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:

Responsible Party: Jing Zeng, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT02204761     History of Changes
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    Key Record Dates
Results First Posted: November 20, 2018
Last Update Posted: November 20, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Neoplasms
Neoplasms, Second Primary
Thoracic Neoplasms
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Neoplasms
Lung Diseases
Respiratory Tract Diseases