Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)

Completed · Not applicable

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID: NCT00875901
Run by: University of Florida
People needed: 23
Starts: 2009-09-01
Expected to finish: 2022-03-21
Last updated by the study team: 2022-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Florida Proton Therapy Institute — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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