VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Larynx Cancer

NARecruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

November 20, 2019

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2030

Conditions
Glottis TumorLarynx Cancer
Interventions
RADIATION

Single Vocal Cord Irradiation (SVCI)

The following planning aim will be pursued: full coverage of the PTV with at least 95% of the prescribed dose and a maximum (0.03 cc) PTV dose of \<107%: 16 x 3.63 = 58.08 Gy in 5 fractions per week using 5 to 9 static IMRT or VMAT.

PROCEDURE

Arm A: Transoral CO2-Laser Microsurgical Cordectomy (TLM)

"The TLM has to be performed using a CO2 laser, coupled to an operative microscope, at 4-8W in ultrapulse mode. The type of cordectomy performed must be mentioned using the following classification according the classification of the European Laryngological Society.~The type of resection chosen should provide complete removal of the primary lesion with negative margins.~Surgery will generally be performed within 3 weeks after randomization and not more than 6 weeks after panendoscopy.~The extent of the cordectomy must include a complete anterior, posterior, inferior and supero-lateral mucosal and deep soft tissue margin."

Trial Locations (4)

3010

RECRUITING

Inselspital, Bern University Hospital, Bern

8091

RECRUITING

University Hospital Zurich, Zurich

94805

RECRUITING

Institut Gustave Roussy, Paris

400012

RECRUITING

Tata Memorial Hospital Mumbai, Mumbai

All Listed Sponsors
collaborator

University of Bern

OTHER

collaborator

The Netherlands Cancer Institute

OTHER

collaborator

University of Lausanne Hospitals

OTHER

collaborator

University Hospital, Geneva

OTHER

collaborator

University of Zurich

OTHER

lead

Olgun Elicin

OTHER