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

University of Florida23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

Peripherally located lung tumorRADIATION

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)

Centrally located lung tumorRADIATION

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer.

Time frame: 1 year after the end of radiation therapy

Secondary Outcomes

Collect and analyze outcome data on tumor control and survival

Time frame: 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

Time frame: 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

Time frame: Before treatment and then when each patient has been followed for a minimum of 12 months to a maxiumum of 5 years

Data from ClinicalTrials.gov

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