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Trial record 1 of 1 for:    nct02204761
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Proton Beam Radiation Therapy in Treating Patients With Recurrent Thoracic Cancer Who Have Received Prior Radiation Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02204761
First Posted: July 30, 2014
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
  Purpose
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 Intervention
Metastatic Malignant Neoplasm in the Lung Recurrent Disease Thoracic Neoplasm Radiation: Proton Beam Radiation Therapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Grade 2 toxicity attributable to radiation treatment [ Time Frame: Up to 3 months post-treatment ]
    Toxicity will be graded based on CTCAE 4.0.

  • Local control [ Time Frame: Up to 3 months post-treatment ]
    Failure: 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.

  • Overall survival [ Time Frame: Up to 3 months post-treatment ]
    Failure: death due to any cause.


Enrollment: 6
Actual Study Start Date: September 9, 2014
Estimated Primary Completion Date: February 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (proton beam radiation therapy)
Patients undergo proton beam radiation therapy per standard of care.
Radiation: Proton Beam Radiation Therapy
Undergo proton beam radiation therapy

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
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
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
  More Information

Responsible Party: 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: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: July 28, 2014
First Posted: July 30, 2014
Last Update Posted: October 2, 2017
Last Verified: September 2017

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