Hypofractionated Radiotherapy for Lung Cancer

Lung Cancer Clinical Trial

Official title:

The Use of Helical Tomotherapy to Achieve Dose-per-fraction Escalation in Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214123
• Other study ID #: RO04502
• Secondary ID: A533300SMPH\HUMA
• Status: Completed
• Phase: Phase 1
• Start date: June 2004
• Est. completion date: December 2012

Study information

• Verified date: July 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Thoracic neoplasm requiring at lest 60 Gy conventional radiotherapy

Exclusion Criteria:

• Prior bleomycin or gemcitabine chemotherapy

• Prior thoracic radiotherapy

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• radiation therapy (radiotherapy)
Bin assignment based on tumor volume

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade 3 pneumonitis lasting greater than 2 weeks		90 days post radiotherapy (XRT)