Phase II Study of IMRT With SIB as Adjuvant Treatment for... | NCT00279721

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

NCT00279721

Sponsor

Alberta Health services

Status

Completed

Last Update Posted

Jan 19, 2012Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

Thyroid Neoplasms

Interventions

IMRT

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jan 18, 2006

First Submission Date that Met QC Criteria

Jan 18, 2006

First Posted Date

Jan 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2012

Last Update Posted Date

Jan 19, 2012Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
IMRT	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
toxicity according to RTOG criteria
locoregional control

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Harold Lau, MD	Tom Baker Cancer Centre	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided