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

March 23, 2022 updated by: University of Florida

Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32206
        • University of Florida Proton Therapy Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year after the end of radiation therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Before treatment and then when each patient has been followed for a minimum of 12 months to a maxiumum of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

March 21, 2022

Study Completion (Actual)

March 21, 2022

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 3, 2009

First Posted (Estimate)

April 6, 2009

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPTI 0901 - LU03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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