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| Sponsored by: |
University of Wisconsin, Madison |
|---|---|
| Information provided by: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00214123 |
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 I |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | The Use of Helical Tomotherapy to Achieve Dose-Per-Fraction Escalation in Lung Cancer |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Bin 1: Experimental
bin assignment based on tumor volume
|
Radiation: radiation therapy (radiotherapy)
Bin assignment based on tumor volume
|
|
Bin 2: Experimental
Bin assignment based on tumor volume
|
Radiation: radiation therapy (radiotherapy)
Bin assignment based on tumor volume
|
|
Bin 3: Experimental
Bin assignment based on tumor volume
|
Radiation: radiation therapy (radiotherapy)
Bin assignment based on tumor volume
|
|
Bin 4: Experimental
Bin assignment based on tumor volume
|
Radiation: radiation therapy (radiotherapy)
Bin assignment based on tumor volume
|
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Bin 5: Experimental
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Cancer Connect | 800-622-8922 |
| United States, Wisconsin | |
| University of Wisconsin Hospital and Clinics | Recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Contact: Cancer Connect 800-622-8922 | |
| Principal Investigator: | Minesh Mehta, MD | University of Wisconsin, Madison |
More Information
| Responsible Party: | University of Wisconsin Comprehensive Cancer Center ( Minesh Mehta ) |
| Study ID Numbers: | RO04502 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00214123 |
| Health Authority: | United States: Institutional Review Board |
|
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
|
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |
