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

Study Overview
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Brief Summary
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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.

Official Title
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Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Peripherally located lung tumor
* Radiation: Centrally located lung tumor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripherally located lung tumor<br>12 cobalt gray equivalent per fraction to a total of 48 cobalt gray equivalent | Radiation: Peripherally located lung tumor<br>* 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)<br>* Other names: Proton Radiation;|
| Experimental: Centrally located lung tumor<br>6 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent | Radiation: Centrally located lung tumor<br>* 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)<br>* Other names: Proton Radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer. |  | 1 year after the end of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and analyze outcome data on tumor control and survival |  | When each patient has been followed for a minimum of 12 months to a maximum of 5 years | 
| Assess differences in dosimetric values compared with photons for lung, heart, esophagus, spinal cord, skin and brachial plexus |  | When each patient has been followed for a minimum of 12 months to a maximum of 5 years | 
| Assess changes in quality of life before and after treatment |  | Before treatment and then when each patient has been followed for a minimum of 12 months to a maxiumum of 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Stage I Non-Small Cell Lung Cancer, Proton Radiation, HypoIGRT