At a glance
ClinicalIndex Comparison Record- ✓ECOG performance status 0-1 at registration
- ✓Age ≥18 years
- ✓Histopathologically confirmed, previously untreated unilateral cT1a or cTis stage 0 or I glottic larynx cancer
- ✓History and physical examination by head and neck surgeon and radiation oncologist within 28 days prior registration
- ✕Infection hampering voice quality at time of voice assessment
- ✕Tumor involvement of the anterior commissure
- ✕Previous oncologic surgery with curative intent or radiotherapy to larynx (exception: excisional biopsies with unacceptable close margins may be included)
- ✕Synchronous or previous malignancies (exceptions: adequately treated basal cell carcinoma/SCC of skin, in situ cervix carcinoma, low-risk prostate cancer or breast with ≥3 years cancer-free follow-up, or other malignancy with ≥5 years progression-free interval)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Single Vocal Cord Irradiation (SVCI) and Arm A: Transoral CO2-Laser Microsurgical Cordectomy (TLM) for Glottis Tumor and Larynx Cancer. Currently recruiting, targeting 34 participants across 4 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.