RecruitingNot ApplicableNCT04057209

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

VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Unilateral Stage 0 & I Glottic Larynx Cancer - A Randomized Phase III Trial


Sponsor

Olgun Elicin

Enrollment

34 participants

Start Date

Nov 20, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two treatments for early-stage larynx cancer (cancer of the vocal cords): laser surgery that removes the cancer through the mouth (transoral CO2 laser surgery) versus single-fraction radiotherapy (one high-precision dose of radiation). The primary focus is on voice quality — which treatment preserves the patient's voice better? **You may be eligible if...** - You have been newly diagnosed with early-stage glottic larynx cancer (Stage 0 or Stage I, affecting one vocal cord only) confirmed by biopsy - You have an ECOG performance status of 0-1 (fully active or able to carry out light activities) - You are 18 or older - Your tumor is accessible for laser surgery (confirmed by an exam under anesthesia) - Your tumor can be completely removed with at least 2 mm of clear margins without damaging the arytenoid cartilage or extending to the other vocal cord - Your hemoglobin is at least 10 g/dL **You may NOT be eligible if...** - You have previously received treatment for this cancer - Your cancer affects both vocal cords or has spread beyond the larynx - The tumor cannot be accessed safely by transoral surgery - You are unable to tolerate either of the study treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONSingle Vocal Cord Irradiation (SVCI)

The following planning aim will be pursued: full coverage of the PTV with at least 95% of the prescribed dose and a maximum (0.03 cc) PTV dose of \<107%: 16 x 3.63 = 58.08 Gy in 5 fractions per week using 5 to 9 static IMRT or VMAT.

PROCEDUREArm A: Transoral CO2-Laser Microsurgical Cordectomy (TLM)

The TLM has to be performed using a CO2 laser, coupled to an operative microscope, at 4-8W in ultrapulse mode. The type of cordectomy performed must be mentioned using the following classification according the classification of the European Laryngological Society. The type of resection chosen should provide complete removal of the primary lesion with negative margins. Surgery will generally be performed within 3 weeks after randomization and not more than 6 weeks after panendoscopy. The extent of the cordectomy must include a complete anterior, posterior, inferior and supero-lateral mucosal and deep soft tissue margin.


Locations(4)

Institut Gustave Roussy

Paris, France

Tata Memorial Hospital Mumbai

Mumbai, Maharashtra, India

Inselspital, Bern University Hospital

Bern, Canton of Bern, Switzerland

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04057209


Related Trials