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Hypofractionated Radiotherapy for Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214123
First received: September 13, 2005
Last updated: January 22, 2013
Last verified: January 2013

September 13, 2005
January 22, 2013
June 2004
December 2012   (final data collection date for primary outcome measure)
Grade 3 pneumonitis lasting greater than 2 weeks [ Time Frame: 90 days post radiotherapy (XRT) ] [ Designated as safety issue: Yes ]
To establish feasibility using tomotherapy to treat lung cancer
Complete list of historical versions of study NCT00214123 on ClinicalTrials.gov Archive Site
Not Provided
To conduct phase I dose-per-fraction escalation with grade 3 pneumonitis as MTD
Not Provided
Not Provided
 
Hypofractionated Radiotherapy for Lung Cancer
The Use of Helical Tomotherapy to Achieve Dose-per-fraction Escalation in Lung Cancer

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Lung Cancer
Radiation: radiation therapy (radiotherapy)
Bin assignment based on tumor volume
  • Experimental: Bin 1
    bin assignment based on tumor volume
    Intervention: Radiation: radiation therapy (radiotherapy)
  • Experimental: Bin 2
    Bin assignment based on tumor volume
    Intervention: Radiation: radiation therapy (radiotherapy)
  • Experimental: Bin 3
    Bin assignment based on tumor volume
    Intervention: Radiation: radiation therapy (radiotherapy)
  • Experimental: Bin 4
    Bin assignment based on tumor volume
    Intervention: Radiation: radiation therapy (radiotherapy)
  • Experimental: Bin 5
    Bin assignment based on tumor volume
    Intervention: Radiation: radiation therapy (radiotherapy)
Cannon DM, Mehta MP, Adkison JB, Khuntia D, Traynor AM, Tomé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Thoracic neoplasm requiring at lest 60 Gy conventional radiotherapy

Exclusion Criteria:

  • Prior bleomycin or gemcitabine chemotherapy
  • Prior thoracic radiotherapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00214123
RO04502
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Anne Traynor, MD University of Wisconsin, Madison
University of Wisconsin, Madison
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP