VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Larynx Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOlgun Elicin
About this trial
Laser surgery and radiotherapy are well-established standards of care for unilateral stage 0 \& I carcinoma in situ (Cais) and squamous cell carcinoma of glottic larynx (SCCGL). Based on meta-analyses, functional and oncological outcome after both treatment modalities are comparable1-5. However, no properly conducted randomized trials comparing these treatments exist. The only such trial with the endpoint of voice quality had to be prematurely closed due to low accrual6.
The traditional radiotherapy involves the treatment of the whole larynx. Recently, a new radiotherapy technique was introduced by a team of researchers from Netherlands, where the treated target volume consists of involved vocal cord and therefore 8 to 10-fold smaller than the target volumes used for traditional whole larynx irradiation. The treatment is reduced to 16 fractions which corresponds to 3 weeks and a day7-12. The results of a prospective cohort (n=30) with single vocal cord irradiation (SVCI) were compared with the results of a historical prospective cohort previously treated with whole larynx radiotherapy (n=131) in the same institute. The median follow-up was 30 months. The voice handicap index (VHI) at all time points beginning from the 6th week after SVCI was significantly superior to the same time points with conventional radiotherapy. Moreover, a comparable local control with SVCI (100%) vs. conventional radiotherapy (92%) was reported at two years, p=0.2412.
Based on this information, the investigators' main aim is to compare SVCI to Transoral CO2-Laser Microsurgical Cordectomy (TLM) with the main focus of patient-reported voice quality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ECOG performance status 0-1 at the time of registration
≥18 years of age
Baseline assessments and documentation of voice quality by means of VHI, JS, RBH, GNE, SPR
Histopathologically confirmed, previously untreated unilateral (cT1a or unilateral cTis) stage 0 or I glottic larynx cancer based on the UICC staging system (8th edition)
Disqualifiers
Infection hampering the voice quality at the time of voice assessment
Involvement of the anterior commissure by the tumor
Previous oncologic surgery with curative intent (exception: excisional biopsies resulting in unacceptable close R0 or R1/R2 margins may be included) or radiotherapy to larynx
Synchronous or previous malignancies. Exceptions are adequately treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low-risk prostate cancer or breast with a cancer-free follow-up time of at least 3 years, or other previous malignancy with a progression-free interval of at least 5 years
Trial design
Design model
Parallel
Treatments tested in this trial
Single Vocal Cord Irradiation (SVCI)
RadiationThe 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.
Arm A: Transoral CO2-Laser Microsurgical Cordectomy (TLM)
Procedure/SurgeryThe 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.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Arm A: Transoral CO2-Laser Microsurgical Cordectomy (TLM)Active comparator 1 intervention
Group B: Arm B: Single Vocal Cord Irradiation (SVCI)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Voice Handicap Index
average of the VHI scores (range: 0-120) of each patient up to 24 months after randomization
Time frame
up to 2 yearsSecondary outcomes
1
Roughness - Breathiness - Hoarseness (RBH)
The perceptual impression of a vocal signal remains the gold standard in phoniatric diagnosis. By means of reading the phonetically balanced text "The Rainbow Passage" in English and "Die Sonne und der Wind" in German, French and Italian (versions in different languages provided in the protocol), the speaking voice is assessed by the investigator according to the parameters roughness - breathiness - hoarseness (RBH), using the scale of 0: normal, 1: mild, 2: moderate, 3: severe. In this study, the assessment will be carried out blind.
Time frame
6, 12, 18, and 24 months2
Jitter and shimmer (JS)
JS are regarded as objective, quantitative characteristics of voice quality. They describe the variations in the fundamental note of a vocal signal. Jitter is the variation of the cycle-to-cycle frequency in held vowels (in Hz or. %, norm = 0-3%), shimmer is the cycle-to-cycle variation in the amplitude of held vowels (in dB, or. %, norm = 0-20%). In this study, the assessment will be carried out blind.
Time frame
6, 12, 18, and 24 months3
Glottal-to-Noise Excitation Ratio (GNE)
GNE serves to describe the relationship of the voice signal to the noise signal (norm = 1-0) and is also a quantitative characteristic of voice quality. Jitter, shimmer and GNE correspond to the perceptual characteristics roughness - breathiness - hoarseness. In order to carry out jitter, shimmer and GNE, the test subjects hold the vowel /a/ mezzoforte for at least 5 seconds at their average speaking pitch. The vocal samples will be recorded and subsequently evaluated using the open source freeware software Praat (http://www.fon.hum.uva.nl/praat/ by Paul Boersma and David Weenink - Phonetic Sciences, University of Amsterdam Spuistraat 210 1012VT Amsterdam, Netherlands). In this study, the assessment will be carried out blind.
Time frame
6, 12, 18, and 24 months4
Singing Power Ratio (SPR)
The 'brilliant' sound of a voice is characterized in acoustic terms by a high degree of acoustic energy above 2 kHz. This can be calculated with the aid of the SPR. In the Fast-Fourier-Transformation, the amplitudes of the highest peaks between 2 and 4 kHz and of the highest peaks between 0 and 2 kHz are determined using a vocal sample and the one subtracted from the other. The lower the SPR, the more "sonorous" is the voice. For this, the test subjects hold the vowel /a/ mezzoforte for at least 5 seconds at their average speaking pitch. The vocal samples will be recorded and subsequently evaluated using Praat. In this study, the assessment will be carried out blind.
Time frame
6, 12, 18, and 24 monthsSponsors and contacts
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Olgun Elicin
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Sponsor institution
University of Bern
Collaborator
The Netherlands Cancer Institute
Collaborator
University of Lausanne Hospitals
Collaborator
University Hospital, Geneva
Collaborator
University of Zurich
Collaborator
Source ClinicalTrials.gov