Hypofractionated Radiotherapy for Lung Cancer
The Use of Helical Tomotherapy to Achieve Dose-per-fraction Escalation in Lung Cancer
4 other identifiers
interventional
79
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 lung-cancer
Started Jun 2004
Longer than P75 for phase_1 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 13, 2019
July 1, 2015
8.5 years
September 13, 2005
December 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Grade 3 pneumonitis lasting greater than 2 weeks
90 days post radiotherapy (XRT)
Study Arms (5)
Bin 1
EXPERIMENTALbin assignment based on tumor volume
Bin 2
EXPERIMENTALBin assignment based on tumor volume
Bin 3
EXPERIMENTALBin assignment based on tumor volume
Bin 4
EXPERIMENTALBin assignment based on tumor volume
Bin 5
EXPERIMENTALBin assignment based on tumor volume
Interventions
Bin assignment based on tumor volume
Eligibility Criteria
You may qualify if:
- Thoracic neoplasm requiring at lest 60 Gy conventional radiotherapy
You may not qualify if:
- Prior bleomycin or gemcitabine chemotherapy
- Prior thoracic radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Related Publications (1)
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.
PMID: 24145340DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Traynor, MD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
June 1, 2004
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 13, 2019
Record last verified: 2015-07