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
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Malignant Neoplasm in the Lung Recurrent Disease Thoracic Neoplasm||Radiation: Proton Beam Radiation Therapy||Not Applicable|
I. To assess the grade 3 toxicity associated with thoracic re-irradiation with proton therapy, with prospectively applied normal organ radiation dose limits.
I. To assess the efficacy of thoracic re-irradiation with proton therapy.
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)|
|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|
Proton beam radiation therapy
Radiation: Proton Beam Radiation Therapy
Undergo proton beam re-irradiation therapy
- 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.
- 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.
- 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.
- Number of Participants Alive [ Time Frame: Up to 3 months post-treatment ]Number of participants alive.
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
|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|
|Principal Investigator:||Jing Zeng||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|