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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peripherally located lung tumor
Centrally located lung tumor
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Lung Cancer, Stage I Non-Small Cell Lung Cancer, Proton Radiation, HypoIGRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Florida Proton Therapy Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Peripherally located lung tumor

Centrally located lung tumor

Arm Description

12 cobalt gray equivalent per fraction to a total of 48 cobalt gray equivalent

6 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent

Outcomes

Primary Outcome Measures

Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer.

Secondary Outcome Measures

Collect and analyze outcome data on tumor control and survival
Assess differences in dosimetric values compared with photons for lung, heart, esophagus, spinal cord, skin and brachial plexus
Assess changes in quality of life before and after treatment

Full Information

First Posted
April 2, 2009
Last Updated
March 23, 2022
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00875901
Brief Title
Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)
Acronym
LU03
Official Title
Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
March 21, 2022 (Actual)
Study Completion Date
March 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Lung Cancer, Stage I Non-Small Cell Lung Cancer, Proton Radiation, HypoIGRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peripherally located lung tumor
Arm Type
Experimental
Arm Description
12 cobalt gray equivalent per fraction to a total of 48 cobalt gray equivalent
Arm Title
Centrally located lung tumor
Arm Type
Experimental
Arm Description
6 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent
Intervention Type
Radiation
Intervention Name(s)
Peripherally located lung tumor
Other Intervention Name(s)
Proton Radiation
Intervention Description
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)
Intervention Type
Radiation
Intervention Name(s)
Centrally located lung tumor
Other Intervention Name(s)
Proton Radiation
Intervention Description
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)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romaine C Nichols, MD
Organizational Affiliation
University of Florida Proton Therapy Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Proton Therapy Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)

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