Voice Quality after Transoral CO2-Laser Surgery versus Single Vocal Cord Irradiation for Unilateral Stage 0 & I Glottic Larynx Cancer â?? A Randomized Phase III Trial - VoiceS

the Insel Gruppe AG Universittsklinik fr Allgemeine Innere Medizin Bern Switzerland0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年1月9日

试验速览

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•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

发起方

the Insel Gruppe AG Universittsklinik fr Allgemeine Innere Medizin Bern Switzerland