Text Size

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
History of Changes
  Purpose

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 Intervention Phase
Lung Cancer
 Radiation: radiation therapy (radiotherapy)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Use of Helical Tomotherapy to Achieve Dose-per-fraction Escalation in Lung Cancer

Resource links provided by NLM:

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

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Grade 3 pneumonitis lasting greater than 2 weeks [ Time Frame: 90 days post radiotherapy (XRT) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2004
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214123     History of Changes
Other Study ID Numbers: RO04502
Study First Received: September 13, 2005
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013