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

Status

Completed

Conditions

Intervention / Treatment

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.

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

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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