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

Korábbi kezelés

• 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
• Illness requiring hospitalization or precluding study therapy within 28 days before registration

Más betegség

• Infection hampering the voice quality at the time of voice assessment
• 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
• 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

Egyéb

• Involvement of the anterior commissure by the tumor

• 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.