Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)
NCT ID: NCT00875901
Last Updated: 2022-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2009-09-30
2022-03-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peripherally located lung tumor
12 cobalt gray equivalent per fraction to a total of 48 cobalt gray equivalent
Peripherally located lung tumor
12 cobalt gray equivalent per fraction for 4 fractions, 2-3 treatments per week (every other day), over 2 weeks for a total of 48 cobalt gray equivalent (Fractions at lest 40 hours apart)
Centrally located lung tumor
6 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent
Centrally located lung tumor
6 cobalt gray equivalent per fraction for 10 fractions, 5 treatments per week over 2-3 weeks for a total of 60 cobalt gray equivalent (no more than one fraction per calendar day)
Interventions
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Peripherally located lung tumor
12 cobalt gray equivalent per fraction for 4 fractions, 2-3 treatments per week (every other day), over 2 weeks for a total of 48 cobalt gray equivalent (Fractions at lest 40 hours apart)
Centrally located lung tumor
6 cobalt gray equivalent per fraction for 10 fractions, 5 treatments per week over 2-3 weeks for a total of 60 cobalt gray equivalent (no more than one fraction per calendar day)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* T1, N0, M0 or T2, N0, M0. (AJCC Lung 7th Edition)
* At least 18 years old at the time of consent.
* Adequate bone marrow function.
* Medically inoperable. Medically operable candidates are allowed if they refuse surgical resection.
* If the patient has a large pleural effusion, it must be biopsy negative.
Exclusion Criteria
* Synchronous primary.
* T2 tumors \> 5 cm; T3, T4 primary tumor.
* Previous radiotherapy for lung cancer.
* Concomitant local, regional, and/or systemic therapy during radiotherapy.
* Active systemic, pulmonary, and/or pericardial infection.
18 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Romaine C Nichols, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida Proton Therapy Institute
Locations
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University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Countries
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References
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Other Identifiers
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UFPTI 0901 - LU03
Identifier Type: -
Identifier Source: org_study_id
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