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Hypofractionated Radiotherapy for Lung Cancer

NCT ID: NCT00214123

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Bin 1

bin assignment based on tumor volume

Group Type EXPERIMENTAL

radiation therapy (radiotherapy)

Intervention Type RADIATION

Bin assignment based on tumor volume

Bin 2

Bin assignment based on tumor volume

Group Type EXPERIMENTAL

radiation therapy (radiotherapy)

Intervention Type RADIATION

Bin assignment based on tumor volume

Bin 3

Bin assignment based on tumor volume

Group Type EXPERIMENTAL

radiation therapy (radiotherapy)

Intervention Type RADIATION

Bin assignment based on tumor volume

Bin 4

Bin assignment based on tumor volume

Group Type EXPERIMENTAL

radiation therapy (radiotherapy)

Intervention Type RADIATION

Bin assignment based on tumor volume

Bin 5

Bin assignment based on tumor volume

Group Type EXPERIMENTAL

radiation therapy (radiotherapy)

Intervention Type RADIATION

Bin assignment based on tumor volume

Interventions

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radiation therapy (radiotherapy)

Bin assignment based on tumor volume

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Thoracic neoplasm requiring at lest 60 Gy conventional radiotherapy

Exclusion Criteria

* Prior bleomycin or gemcitabine chemotherapy
* Prior thoracic radiotherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Traynor, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24145340 (View on PubMed)

Other Identifiers

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A533300

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\HUMAN ONCOLOGY\HUMAN ONCO

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-00868

Identifier Type: REGISTRY

Identifier Source: secondary_id

RO04502

Identifier Type: -

Identifier Source: org_study_id