the Comparison of Voice Quality in Early Laryngeal Cancer... | NCT00497588

Studies
the Comparison of Voice Quality in Early Laryngeal Cancer Between Surgery and Radiotherapy

NCT00497588

Sponsor

Tehran University of Medical Sciences

Status

Unknown status

Last Update Posted

Jul 11, 2013Estimated

Enrollment

33Estimated

Phase

Phase 3

Conditions

Voice Quality

Interventions

surgery
radiotherapy

Countries

Iran

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 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Apr 2014Estimated

Completion Date

Apr 2014Estimated

First Submitted Date

Jul 4, 2007

First Submission Date that Met QC Criteria

Jul 5, 2007

First Posted Date

Jul 6, 2007Estimated

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

Jul 10, 2013

Last Update Posted Date

Jul 11, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Babak Saedi, associate Professor, Tehran University of Medical SciencesPrincipal Investigator

Lead Sponsor

Tehran University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

early laryngeal cancer is a well known field with great controversy in treatment. two options are available in treatment of patients the first one is partial laryngectomy and the second one is radiotherapy.one of major concern of patients have been the quality of voice ,so we design this trial to answer the priority of each options.

Detailed Description

early laryngeal cancer is a well known field with great controversy in treatment. two options are available in treatment of patients the first one is partial laryngectomy and the second one is radiotherapy.one of major concern of patients have been the quality of voice as part of quality of life ,so we design this clinical randomised trial to answer the priority of each options.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
radiotherapy	Active Comparator	patients receive radiotherapy	Radiation: radiotherapy
surgery	Experimental	Patients undergo surgery	Procedure: surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery	Procedure		surgery
radiotherapy

Measure	Description	Time Frame
quality of voice		3 to 6 month after therapy

Measure	Description	Time Frame
quality of life		6 month later

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Early laryngeal cancer

Exclusion Criteria:

No history of radiotherapy and collagen vascular disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
babak saedi, professor	Contact	98219123872469		saedi@tums.ac.ir
mohamad sadeghi, professor	Contact	98219121153594		sadeghi@tums.ac.ir

Overall Officials

Name	Affiliation	Role
babak saedi, professor	tehran university of medical science	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imam Khomainee hospital	Recruiting	Tehran	Tehran Province	19799	Iran

Condition Browse Module

MeSH Terms

ID	Term
D007822	Laryngeal Neoplasms

Ancestor Terms

ID	Term
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative
D011878	Radiotherapy

Ancestor Terms

ID	Term
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided