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

Thyroid Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279721
• Other study ID #: 18916
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2006
• Last updated: January 18, 2012
• Start date: January 2006
• Est. completion date: June 2010

Study information

• Verified date: July 2011
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• IMRT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Health Services

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	toxicity according to RTOG criteria
Primary	locoregional control