NCT05289336

Brief Summary

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

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
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

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

September 1, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

3.7 years

First QC Date

March 13, 2022

Last Update Submit

March 13, 2022

Conditions

Head and Neck Squamous Cell CarcinomaGlottic T1

Keywords

Transoral laser microsurgeryAccelerated radiotherapy

Outcome Measures

Primary Outcomes (1)

  • laryncegtomy free survival

    Alive with larynx

    5 years

Secondary Outcomes (6)

  • Local control

    5 years

  • Ultimate tumor control

    5 years

  • Overall survival

    5 years

  • Voice quality

    3 years

  • Radiation free survival

    5 years

  • +1 more secondary outcomes

Study Arms (1)

Transoral Laser Microsurgery

EXPERIMENTAL

Transoral Laser Microsurgery

Procedure: Transoral Laser Microsurgery

Interventions

Transoral Laser MicrosurgeryPROCEDURE
Transoral Laser Microsurgery

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Aalborg University Hospital

Aalborg, Denmark

Location

Department of Experimental Clinical Oncology, Aarhus University Hospital

Aarhus, 8000 C, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Nina M Lyhne, MD

    Aalborg University Hospital, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Phase 2 prospective non-inferiority trial comparing with previous prospective collected national cohort
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

March 13, 2022

First Posted

March 21, 2022

Study Start

September 1, 2012

Primary Completion

April 30, 2016

Study Completion

May 1, 2022

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations

DK(5)