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Hypofractionated Radiotherapy for Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
radiation therapy (radiotherapy)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: Thoracic neoplasm requiring at lest 60 Gy conventional radiotherapy Exclusion Criteria: Prior bleomycin or gemcitabine chemotherapy Prior thoracic radiotherapy

Sites / Locations

  • University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Bin 1

Bin 2

Bin 3

Bin 4

Bin 5

Arm Description

bin assignment based on tumor volume

Bin assignment based on tumor volume

Bin assignment based on tumor volume

Bin assignment based on tumor volume

Bin assignment based on tumor volume

Outcomes

Primary Outcome Measures

Grade 3 pneumonitis lasting greater than 2 weeks

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
December 12, 2019
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00214123
Brief Title
Hypofractionated Radiotherapy for Lung Cancer
Official Title
The Use of Helical Tomotherapy to Achieve Dose-per-fraction Escalation in Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to pilot reducing the duration of radiation treatment for lung cancer patients from 6 to 5 weeks using tomotherapy. Specific patient doses will be based on tumor volume being treated. Modeling has shown that increased biologically effective dose (BED) to tumors can be achieved by shortening the radiation delivery schedule and increasing the dose per fraction. This requires decreasing the total dose to hold lung toxicity constant at each dose per fraction level. This is a major paradigm shift in the treatment in this disease and is projected to result in significant improvements in patient outcome as well as a substantial cost savings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bin 1
Arm Type
Experimental
Arm Description
bin assignment based on tumor volume
Arm Title
Bin 2
Arm Type
Experimental
Arm Description
Bin assignment based on tumor volume
Arm Title
Bin 3
Arm Type
Experimental
Arm Description
Bin assignment based on tumor volume
Arm Title
Bin 4
Arm Type
Experimental
Arm Description
Bin assignment based on tumor volume
Arm Title
Bin 5
Arm Type
Experimental
Arm Description
Bin assignment based on tumor volume
Intervention Type
Radiation
Intervention Name(s)
radiation therapy (radiotherapy)
Intervention Description
Bin assignment based on tumor volume
Primary Outcome Measure Information:
Title
Grade 3 pneumonitis lasting greater than 2 weeks
Time Frame
90 days post radiotherapy (XRT)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Thoracic neoplasm requiring at lest 60 Gy conventional radiotherapy Exclusion Criteria: Prior bleomycin or gemcitabine chemotherapy Prior thoracic radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Traynor, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24145340
Citation
Cannon DM, Mehta MP, Adkison JB, Khuntia D, Traynor AM, Tome WA, Chappell RJ, Tolakanahalli R, Mohindra P, Bentzen SM, Cannon GM. Dose-limiting toxicity after hypofractionated dose-escalated radiotherapy in non-small-cell lung cancer. J Clin Oncol. 2013 Dec 1;31(34):4343-8. doi: 10.1200/JCO.2013.51.5353. Epub 2013 Oct 21.
Results Reference
derived

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Hypofractionated Radiotherapy for Lung Cancer

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