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CompletedNCT00214123Updated Dec 13, 2019

Hypofractionated Radiotherapy for Lung Cancer

A Phase 1 interventional study of radiation therapy (radiotherapy) in Lung Cancer, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-13.

Sponsored by University of Wisconsin, Madison · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
79
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Lung Cancer

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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 79 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Thoracic neoplasm requiring at lest 60 Gy conventional radiotherapy

Exclusion criteria

Exclusion Criteria:

  • Prior bleomycin or gemcitabine chemotherapy
  • Prior thoracic radiotherapy
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Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
79 participants (actual)

Study arms

  • Experimental
    Bin 1

    bin assignment based on tumor volume

    Radiation: radiation therapy (radiotherapy)

  • Experimental
    Bin 2

    Bin assignment based on tumor volume

    Radiation: radiation therapy (radiotherapy)

  • Experimental
    Bin 3

    Bin assignment based on tumor volume

    Radiation: radiation therapy (radiotherapy)

  • Experimental
    Bin 4

    Bin assignment based on tumor volume

    Radiation: radiation therapy (radiotherapy)

  • Experimental
    Bin 5

    Bin assignment based on tumor volume

    Radiation: radiation therapy (radiotherapy)

Interventions

  • Radiationradiation therapy (radiotherapy)

    Bin assignment based on tumor volume

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What researchers measure

Primary outcomes

  1. Grade 3 pneumonitis lasting greater than 2 weeks

    Time frame: 90 days post radiotherapy (XRT)

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Study locations

1 site
  • University of Wisconsin Hospital and Clinics
    Madison, Wisconsin 53792, United States
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References and documents

Publications

  • 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. PubMed 24145340 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00214123
Lead sponsor
University of Wisconsin, Madison
Responsible party
Sponsor
First posted
Sep 21, 2005
Start date
Jun 2004
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Dec 13, 2019

Study contacts

Anne Traynor, MD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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