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

University of Florida

Status: Completed

Conditions: Non-Small Cell Lung Cancer

Treatments: Radiation: Peripherally located lung tumor; Radiation: Centrally located lung tumor

Study type: Interventional

Funder types: Other

Identifiers

NCT00875901

UFPTI 0901 - LU03

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. (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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Peripherally located lung tumor

Experimental group

Description:

12 cobalt gray equivalent per fraction to a total of 48 cobalt gray equivalent

Treatment:

Radiation: Peripherally located lung tumor

Centrally located lung tumor

Experimental group

Description:

6 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent

Treatment:

Radiation: Centrally located lung tumor