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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)

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

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

Outcomes

Primary Outcome Measures

Grade 3 pneumonitis lasting greater than 2 weeks

Secondary Outcome Measures

Full Information

NCT ID

NCT00214123

First Posted

September 13, 2005

Last Updated

December 12, 2019

Sponsor

University of Wisconsin, Madison

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

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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