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

July 10, 2013 updated by: Babak Saedi, Tehran University of Medical Sciences
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

33

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 19799
        • Recruiting
        • Imam Khomainee hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mohamad sadeghi, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Early laryngeal cancer

Exclusion Criteria:

  • No history of radiotherapy and collagen vascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: radiotherapy
patients receive radiotherapy
Radiation: radiotherapy
Experimental: surgery
Patients undergo surgery
Procedure: surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life
Time Frame: 6 month later
6 month later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: babak saedi, professor, tehran university of medical science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

July 4, 2007

First Submitted That Met QC Criteria

July 5, 2007

First Posted (Estimate)

July 6, 2007

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • bs-86-01-48-5497

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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