NCT04057209 VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Larynx Cancer
| NCT ID | NCT04057209 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Olgun Elicin |
| Condition | Glottis Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2019-11-20 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2019-11-20 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, functional and oncological outcome after both treatment modalities are comparable1-5. However, no properly conducted randomized trials comparing these treatments exist. The only such trial with the endpoint of voice quality had to be prematurely closed due to low accrual6. The traditional radiotherapy involves the treatment of the whole larynx. Recently, a new radiotherapy technique was introduced by a team of researchers from Netherlands, where the treated target volume consists of involved vocal cord and therefore 8 to 10-fold smaller than the target volumes used for traditional whole larynx irradiation. The treatment is reduced to 16 fractions which corresponds to 3 weeks and a day7-12. The results of a prospective cohort (n=30) with single vocal cord irradiation (SVCI) were compared with the results of a historical prospective cohort previously treated with whole larynx radiotherapy (n=131) in the same institute. The median follow-up was 30 months. The voice handicap index (VHI) at all time points beginning from the 6th week after SVCI was significantly superior to the same time points with conventional radiotherapy. Moreover, a comparable local control with SVCI (100%) vs. conventional radiotherapy (92%) was reported at two years, p=0.2412. Based on this information, the investigators' main aim is to compare SVCI to Transoral CO2-Laser Microsurgical Cordectomy (TLM) with the main focus of patient-reported voice quality.
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
Contact & Investigator
Olgun Elicin, M.D.
PRINCIPAL INVESTIGATOR
Inselspital, Bern University Hospital, 3010 Bern, Switzerland
Frequently Asked Questions
Who can join the NCT04057209 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glottis Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04057209 currently recruiting?
Yes, NCT04057209 is actively recruiting participants. Contact the research team at olgun.elicin@insel.ch for enrollment information.
Where is the NCT04057209 trial being conducted?
This trial is being conducted at Paris, France, Mumbai, India, Bern, Switzerland, Zurich, Switzerland.
Who is sponsoring the NCT04057209 clinical trial?
NCT04057209 is sponsored by Olgun Elicin. The principal investigator is Olgun Elicin, M.D. at Inselspital, Bern University Hospital, 3010 Bern, Switzerland. The trial plans to enroll 34 participants.