DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer

NCT ID: NCT05289336

Last Updated: 2022-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-01

Study Completion Date

2022-05-01

Brief Summary

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To evaluate whether Transoral Laser Microsurgery (TLM) is non-inferior compared to Accelerated Radiotherapy (accRT) in the treatment of T1aN0M0 glottic SCC

Detailed Description

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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

Conditions

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Head and Neck Squamous Cell Carcinoma Glottic T1

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Phase 2 prospective non-inferiority trial comparing with previous prospective collected national cohort
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transoral Laser Microsurgery

Transoral Laser Microsurgery

Group Type EXPERIMENTAL

Transoral Laser Microsurgery

Intervention Type PROCEDURE

Interventions

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Transoral Laser Microsurgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Head and Neck Cancer Group

NETWORK

Sponsor Role lead

Responsible Party

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Jens Overgaard

Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nina M Lyhne, MD

Role: STUDY_CHAIR

Aalborg University Hospital, Denmark

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status

Department of Experimental Clinical Oncology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Aarhus University Hospital

Aarhus, , Denmark

Site Status

Rigshospitalet

Copenhagen, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DAHANCA 27

Identifier Type: -

Identifier Source: org_study_id

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