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

This study is currently recruiting participants.
Verified April 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00875901
First received: April 2, 2009
Last updated: April 21, 2014
Last verified: April 2014
  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:


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:
Publications:
Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2008. CA Cancer J Clin 2008;58:71-96.
Lagerwaard FJ et al Quality of life after stereotactic radiotherapy for medically inoperable stage I lung cancer. International Journal of Radiation Oncology, Biology, Physics IJROBP 2006 Nov1;66(3): S133-S134

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: April 21, 2014
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 April 23, 2014