- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00279721
Phase II Study of IMRT With SIB as Adjuvant Treatment for High Risk Resected Well-differentiated Thyroid Cancer.
January 18, 2012 updated by: Alberta Health services
Phase II Study of Intensity-modulated Radiation (IMRT)With Simultaneous Integrated Boost (SIB) as Adjuvant Treatment for High Risk Resected Well-differentiated Thyroid Cancer.
Resected well-differentiated thyroid neoplasms with at least one high risk feature will receive adjuvant radiation using IMRT with SIB.
The acute toxicity and locoregional control rate at 2 years will be recorded.
Study Overview
Detailed Description
Resected well-differentiated thyroid neoplasms with at least one high risk feature will receive adjuvant radiation using IMRT with SIB.
The acute toxicity and locoregional control rate at 2 years will be recorded.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- resected well-differentiated throid cancer with at least one high risk feature for locoregional recurrence
Exclusion Criteria:
- medullary or anaplastic thyroid cancer, unresectable
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
toxicity according to RTOG criteria
|
locoregional control
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harold Lau, MD, Tom Baker Cancer Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
January 18, 2006
First Submitted That Met QC Criteria
January 18, 2006
First Posted (Estimate)
January 20, 2006
Study Record Updates
Last Update Posted (Estimate)
January 19, 2012
Last Update Submitted That Met QC Criteria
January 18, 2012
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18916
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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