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

Launched by OLGUN ELICIN · Aug 14, 2019

Keywords

ClinConnect Summary

This clinical trial, called VoiceS, is investigating how two different treatments for early-stage larynx cancer affect voice quality. The two treatments being compared are a new type of radiotherapy that targets just the affected vocal cord and a laser surgery technique. Researchers want to find out which option helps patients maintain better voice quality after treatment.

To participate in this trial, patients should be 18 years or older and have a specific type of larynx cancer that hasn't been treated yet. They also need to be in good overall health, as shown by a performance status score, and have a confirmed diagnosis from a medical professional. Participants can expect to receive one of the two treatments and will be monitored for their voice quality over time. It’s important for potential participants to discuss their eligibility with their doctor and understand the commitment involved in the study.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. ECOG performance status 0-1 at the time of registration
• • 2. ≥18 years of age
• • 3. Baseline assessments and documentation of voice quality by means of VHI, JS, RBH, GNE, SPR
• • 4. Histopathologically confirmed, previously untreated unilateral (cT1a or unilateral cTis) stage 0 or I glottic larynx cancer based on the UICC staging system (8th edition)
• • 5. History and physical examination by treating physician (head and neck surgeon and radiation oncologist) within 28 days prior registration
• • 6. The patient must be expected to withstand both study interventions
• • 7. The patient must have undergone panendoscopy with assessment for the feasibility of transoral exposure for resection. Patients without feasible exposure are not eligible
• • 8. 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
• • 9. 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
• • 10. 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.
• • 11. Written informed consent, signed by the patient and the investigator.
• • Exclusion Criteria
• • 1. Infection hampering the voice quality at the time of voice assessment
• • 2. Involvement of the anterior commissure by the tumor
• • 3. 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
• • 4. 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
• • 5. Co-existing disease prejudicing survival (expected survival less than 6 months)
• • 6. Active bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• • 7. History of any voice disorders (not related to the SCCGL) lasting longer than 3 weeks
• • 8. Illness requiring hospitalization or precluding study therapy within 28 days before registration
• • 9. 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