search
Back to results

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

Primary Purpose

Thyroid Neoplasms

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IMRT
Sponsored by
Alberta Health services
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Neoplasms focused on measuring thyroid neoplasms, intensity modulated radiation, radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    toxicity according to RTOG criteria
    locoregional control

    Secondary Outcome Measures

    Full Information

    First Posted
    January 18, 2006
    Last Updated
    January 18, 2012
    Sponsor
    Alberta Health services
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00279721
    Brief Title
    Phase II Study of IMRT With SIB as Adjuvant Treatment for High Risk Resected Well-differentiated Thyroid Cancer.
    Official Title
    Phase II Study of Intensity-modulated Radiation (IMRT)With Simultaneous Integrated Boost (SIB) as Adjuvant Treatment for High Risk Resected Well-differentiated Thyroid Cancer.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    June 2010 (Actual)
    Study Completion Date
    June 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Alberta Health services

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Neoplasms
    Keywords
    thyroid neoplasms, intensity modulated radiation, radiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    IMRT
    Primary Outcome Measure Information:
    Title
    toxicity according to RTOG criteria
    Title
    locoregional control

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Harold Lau, MD
    Organizational Affiliation
    Tom Baker Cancer Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs