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

University of Florida1 site in 1 country23 target enrollmentSeptember 2009

ConditionsNon-Small Cell Lung Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-Small Cell Lung Cancer
Sponsor: University of Florida
Enrollment: 23
Locations: 1
Primary Endpoint: Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

March 21, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Florida

Responsible Party

Sponsor

Eligibility 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, M
•(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.

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(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)