About this trial
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
Qualifiers
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)
Disqualifiers
Infection hampering the voice quality at the time of voice assessment
Involvement of the anterior commissure by the tumor
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
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
Trial design
Treatments tested in this trial
- Single Vocal Cord Irradiation (SVCI)
- Arm A: Transoral CO2-Laser Microsurgical Cordectomy (TLM)
Treatment groups
Sponsors and collaborators
Olgun Elicin
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Sponsor institution
University of Bern
Collaborator
The Netherlands Cancer Institute
Collaborator
University of Lausanne Hospitals
Collaborator
University Hospital, Geneva
Collaborator
University of Zurich
Collaborator