Status:
RECRUITING
VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Larynx Cancer
Lead Sponsor:
Olgun Elicin
Collaborating Sponsors:
University of Bern
The Netherlands Cancer Institute
Conditions:
Glottis Tumor
Larynx Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Background and Rationale Head and neck squamous cell carcinoma (HNSCC) is the 6th most common type of cancer worldwide. Of all head and neck cancers, approximately 30% originates from the larynx. In ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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)
- History and physical examination by treating physician (head and neck surgeon and radiation oncologist) within 28 days prior registration
- The patient must be expected to withstand both study interventions
- The patient must have undergone panendoscopy with assessment for the feasibility of transoral exposure for resection. Patients without feasible exposure are not eligible
- Localization of the tumor should allow resection with a minimum of 2 mm macroscopical margin without extension to the contralateral vocal fold, without partial resection of the arytenoid cartilage and without resection of parts of thyroid cartilage (Cordectomy Type I-IV according the classification of the European Laryngological Society)13
- Hemoglobin ≥10 g/dL or 6.2 mmol/L (Note: The use of transfusion to achieve Hgb ≥10 g/dL is acceptable) within the 28 days prior to accrual
- Women with child-bearing potential and using effective contraception, and not pregnant and agree not to become pregnant (see section 8.6) during participation in the trial and 30 days after radiotherapy. A negative pregnancy test before inclusion (within 28 days) into the trial is required for all women with child-bearing potential. Men agree not to father a child during participation in the trial and 30 days after radiotherapy.
- Written informed consent, signed by the patient and the investigator.
- Exclusion Criteria
- 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
- Co-existing disease prejudicing survival (expected survival less than 6 months)
- Active bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- History of any voice disorders (not related to the SCCGL) lasting longer than 3 weeks
- Illness requiring hospitalization or precluding study therapy within 28 days before registration
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Exclusion
Key Trial Info
Start Date :
November 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2030
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04057209
Start Date
November 20 2019
End Date
November 30 2030
Last Update
October 7 2025
Active Locations (4)
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1
Institut Gustave Roussy
Paris, France, 94805
2
Tata Memorial Hospital Mumbai
Mumbai, Maharashtra, India, 400012
3
Inselspital, Bern University Hospital
Bern, Canton of Bern, Switzerland, 3010
4
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091