A Study of Conventional 3D Radiation vs. Intensity-Modula... | NCT00363441

Studies
A Study of Conventional 3D Radiation vs. Intensity-Modulated Radiation in Squamous Cell Cancer of the Head and Neck

NCT00363441

Sponsor

Alberta Health services

Status

Withdrawn

Last Update Posted

Jan 19, 2012Estimated

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

Head and Neck Neoplasms
Squamous Cell Cancer

Interventions

Intensity Modulated Radiotherapy

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

Jan 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 9, 2006

First Submission Date that Met QC Criteria

Aug 11, 2006

First Posted Date

Aug 15, 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

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Intensity Modulated Radiotherapy	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence and severity of side effects according to Radiation Therapy Oncology Group
scales and CTCAE version 3.0 for acute and chronic radiation toxicities, local control rates

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histologically proven squamous cell carcinoma of the head and neck or squamous cell cancer to the neck from an unknown head and neck primary site, stage I-IV disease which is M0, age greater than 18 years, KPS greater than 70, signed study-specific consent

Exclusion Criteria:

M1; bilateral N3 disease; primary greater than 10cm; salivary gland disease; life expectancy less than 2 years; prior radiotherapy to the head and neck; no signed study-specific consent form

Accepts Healthy Volunteers

Not provided

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

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

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms
D018307	Neoplasms, Squamous Cell

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050397	Radiotherapy, Intensity-Modulated

Ancestor Terms

ID	Term
D020266	Radiotherapy, Conformal
D011881	Radiotherapy, Computer-Assisted
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided