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Hypofractionated Radiotherapy for Lung Cancer

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ClinicalTrials.gov Identifier: NCT00214123
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Radiation: radiation therapy (radiotherapy) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Use of Helical Tomotherapy to Achieve Dose-per-fraction Escalation in Lung Cancer
Study Start Date : June 2004
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Bin 1
bin assignment based on tumor volume
Radiation: radiation therapy (radiotherapy)
Bin assignment based on tumor volume
Experimental: Bin 2
Bin assignment based on tumor volume
Radiation: radiation therapy (radiotherapy)
Bin assignment based on tumor volume
Experimental: Bin 3
Bin assignment based on tumor volume
Radiation: radiation therapy (radiotherapy)
Bin assignment based on tumor volume
Experimental: Bin 4
Bin assignment based on tumor volume
Radiation: radiation therapy (radiotherapy)
Bin assignment based on tumor volume
Experimental: Bin 5
Bin assignment based on tumor volume
Radiation: radiation therapy (radiotherapy)
Bin assignment based on tumor volume


Outcome Measures

Primary Outcome Measures :
  1. Grade 3 pneumonitis lasting greater than 2 weeks [ Time Frame: 90 days post radiotherapy (XRT) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Thoracic neoplasm requiring at lest 60 Gy conventional radiotherapy

Exclusion Criteria:

  • Prior bleomycin or gemcitabine chemotherapy
  • Prior thoracic radiotherapy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214123


Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Anne Traynor, MD University of Wisconsin, Madison
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214123     History of Changes
Other Study ID Numbers: RO04502
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases