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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00875901
Recruitment Status : Active, not recruiting
First Posted : April 6, 2009
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE April 2, 2009
First Posted Date  ICMJE April 6, 2009
Last Update Posted Date September 19, 2018
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2013)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2009)
Confirm the safety of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer. [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT00875901 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2009)
Assess improvements in dosimetric endpoints, acute and late toxicities, disease specific outcomes and quality of life [ Time Frame: Over a 5 year period ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)
Official Title  ICMJE Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • 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
  • 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 (no more than one fraction per calendar day)
    Other Name: Proton Radiation
Study Arms
  • Experimental: Peripherally located lung tumor
    12 cobalt gray equivalent per fraction to a total of 48 cobalt gray equivalent
    Intervention: Radiation: Peripherally located lung tumor
  • Experimental: Centrally located lung tumor
    6 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent
    Intervention: Radiation: Centrally located lung tumor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 3, 2009)
23
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date April 2032
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00875901
Other Study ID Numbers  ICMJE UFPTI 0901 - LU03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bradford S Hoppe, MD, MPH University of Florida Proton Therapy Institute
PRS Account University of Florida
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP