Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)
Conditions
Non-Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Lung Cancer, Stage I Non-Small Cell Lung Cancer, Proton Radiation, HypoIGRT
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Peripherally located lung tumor Type: Radiation
Name: Centrally located lung tumor Type: Radiation
Overall Status
Recruiting
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 surgery. HypoIGRT delivers higher daily doses of radiation over a shorter period of time compared with conventional radiation. This is thought to deliver a more lethal dose of radiation to the tumor and is more convenient with treatment being completed within 2-3 weeks compared to the typical 7-8 week course of conventional radiotherapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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.

- 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:

- 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.
Location
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Status: Recruiting
Contact: Intake Coordinator - 877-686-6009
Start Date
September 2009
Completion Date
April 2032
Sponsors
University of Florida
Source
University of Florida
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page