Clinical Research Directory

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