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

Purpose

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.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Radiation: Peripherally located lung tumor Radiation: Centrally located lung tumor	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	23
Study Start Date:	September 2009
Estimated Study Completion Date:	April 2032
Estimated Primary Completion Date:	June 2025 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Peripherally located lung tumor 12 cobalt gray equivalent per fraction to a total of 48 cobalt gray equivalent	Radiation: Peripherally located lung tumor 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) Other Name: Proton Radiation
Experimental: Centrally located lung tumor 6 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent	Radiation: Centrally located lung tumor 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 (Fractions at least 24 hours apart) Other Name: Proton Radiation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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, M0.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875901

Contacts

Contact: Intake Coordinator

877-686-6009

Locations

United States, Florida
University of Florida Proton Therapy Institute	Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator 877-686-6009
Principal Investigator: Bradford S Hoppe, MD, MPH

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Bradford S Hoppe, MD, MPH

University of Florida Proton Therapy Institute

More Information

Additional Information:

Contact the University of Florida Proton Therapy Institute This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT00875901 History of Changes
Other Study ID Numbers:	UFPTI 0901 - LU03
Study First Received:	April 2, 2009
Last Updated:	March 25, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Lung Cancer
Stage I Non-Small Cell Lung Cancer
Proton Radiation
HypoIGRT

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013