Status:
COMPLETED
Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)
Lead Sponsor:
University of Florida
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a research study to determine if hypofractionated image guided radiation therapy (hypoIGRT) with proton therapy is a good way to treat early stage lung tumors for patients who will not have su...
Eligibility Criteria
Inclusion
- Pathologically confirmed, by biopsy or cytology, non-small cell lung carcinoma diagnosed within 3 months prior to study enrollment.
- 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
- Evidence of distant metastasis (M1) and/or nodal involvement (N1, N2, N3).
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00875901
Start Date
September 1 2009
End Date
March 21 2022
Last Update
March 24 2022
Active Locations (1)
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1
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206