NCT00497588

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

7.1 years

First QC Date

July 4, 2007

Last Update Submit

July 10, 2013

Conditions

Voice Quality

Keywords

laryngeal cancerRADIOTHERAPYVoice Quality

Outcome Measures

Primary Outcomes (1)

  • quality of voice

    3 to 6 month after therapy

Secondary Outcomes (1)

  • quality of life

    6 month later

Study Arms (2)

radiotherapy

ACTIVE COMPARATOR

patients receive radiotherapy

Radiation: radiotherapy

surgery

EXPERIMENTAL

Patients undergo surgery

Procedure: surgery

Interventions

surgeryPROCEDURE
surgery
radiotherapyRADIATION
radiotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Early laryngeal cancer

You may not qualify if:

  • No history of radiotherapy and collagen vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Khomainee hospital

Tehran, Tehran Province, 19799, Iran

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms

Interventions

Surgical Procedures, OperativeRadiotherapy

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • babak saedi, professor

    tehran university of medical science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

babak saedi, professor

CONTACT

98219123872469saedi@tums.ac.ir

mohamad sadeghi, professor

CONTACT

98219121153594sadeghi@tums.ac.ir

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate Professor

Study Record Dates

First Submitted

July 4, 2007

First Posted

July 6, 2007

Study Start

March 1, 2007

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

IR(1)