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Phase II Study of IMRT With SIB as Adjuvant Treatment for High Risk Resected Well-differentiated Thyroid Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00279721
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : January 19, 2012
Sponsor:
Information provided by:
AHS Cancer Control Alberta

Tracking Information
First Submitted Date  ICMJE January 18, 2006
First Posted Date  ICMJE January 20, 2006
Last Update Posted Date January 19, 2012
Study Start Date  ICMJE January 2006
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2006)
  • toxicity according to RTOG criteria
  • locoregional control
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of IMRT With SIB as Adjuvant Treatment for High Risk Resected Well-differentiated Thyroid Cancer.
Official Title  ICMJE Phase II Study of Intensity-modulated Radiation (IMRT)With Simultaneous Integrated Boost (SIB) as Adjuvant Treatment for High Risk Resected Well-differentiated Thyroid Cancer.
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thyroid Neoplasms
Intervention  ICMJE Procedure: IMRT
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 18, 2006)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00279721
Other Study ID Numbers  ICMJE 18916
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Alberta Health Services
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harold Lau, MD Tom Baker Cancer Centre
PRS Account AHS Cancer Control Alberta
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP