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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 23, 2014
Last verified: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 23, 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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on October 01, 2014