DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer (DAHANCA 27)

March 13, 2022 updated by: Jens Overgaard, Danish Head and Neck Cancer Group
To evaluate whether Transoral Laser Microsurgery (TLM) is non-inferior compared to Accelerated Radiotherapy (accRT) in the treatment of T1aN0M0 glottic SCC

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Since 2003 the Danish national standard treatment for T1aN0M0 glottic SCC has been accelerated RT (66Gy. 2 GY/fraction, 6 fractions/week). In 2012 cordectomy type I-III using TLM was introduced as an experimental treatment.

The DAHANCA 27 trial is a comparative non-inferiority phase II study comparing two timely separated national patient cohorts. Patients treated with radical TLM from September 2012 to April 2016 were included in the TLM cohort, and patients treated with accelerated RT from January 2003 to august 2012 were included in the RT cohort

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

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

  • Denmark
      • Aalborg, Denmark
        • Aalborg University Hospital
      • Aarhus, Denmark
        • Aarhus University Hospital
      • Aarhus, Denmark, 8000 C
        • Department of Experimental Clinical Oncology, Aarhus University Hospital
      • Copenhagen, Denmark
        • Rigshospitalet
      • Odense, Denmark
        • Odense University Hospital

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Danish patients aged ≥18 years diagnosed with a T1aN0M0 glottic squamous cell carcinoma (SCC)

Exclusion Criteria:

  • Unable to complete curative intended protocol treatment and/or planned follow up
  • informed concent

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: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transoral Laser Microsurgery
Procedure: Transoral Laser Microsurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
laryncegtomy free survival
Time Frame: 5 years
Alive with larynx
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control
Time Frame: 5 years
Free from disease after primary treatment
5 years
Ultimate tumor control
Time Frame: 5 years
Free from disease after primary treatment including salvage RT or surgery
5 years
Overall survival
Time Frame: 5 years
Death of any cause
5 years
Voice quality
Time Frame: 3 years
Voice Handicap Index score
3 years
Radiation free survival
Time Frame: 5 years
survival without being treated with RT
5 years
any other treatment related morbidity
Time Frame: 5 years
Dahanca morbidity recording
5 years

Collaborators and Investigators

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

Sponsor

Danish Head and Neck Cancer Group

Investigators

  • Study Chair: Nina M Lyhne, MD, Aalborg University Hospital, Denmark

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 (Actual)

September 1, 2012

Primary Completion (Actual)

April 30, 2016

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

March 13, 2022

First Submitted That Met QC Criteria

March 13, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 13, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAHANCA 27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

information can be obtained from the Dahanca database, pending legal and dataprotection accept and relevance

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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