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

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT00875901
Collaborator
(none)
23
Enrollment
1
Location
2
Arms
150.6
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Peripherally located lung tumor
  • Radiation: Centrally located lung tumor
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer
Actual Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Mar 21, 2022
Actual Study Completion Date :
Mar 21, 2022

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 (no more than one fraction per calendar day)
    Other Names:
  • Proton Radiation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer. [1 year after the end of radiation therapy]

    Secondary Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Proton Therapy Institute Jacksonville Florida United States 32206

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: Romaine C Nichols, MD, University of Florida Proton Therapy Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT00875901
    Other Study ID Numbers:
    • UFPTI 0901 - LU03
    First Posted:
    Apr 6, 2009
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    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

    Study Results

    No Results Posted as of Mar 24, 2022