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Compares treatment options for Glottis Tumor
Official title VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Larynx Cancer
ClinicalTrials.gov ID: NCT04057209
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- History and physical examination by treating physician (head and neck surgeon and radiation oncologist) within 28 days prior registration
You likely can't join if
- 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)...
- Synchronous or previous malignancies. Exceptions are adequately treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix...
- Co-existing disease prejudicing survival (expected survival less than 6 months)
- Active bacterial or fungal infection requiring intravenous antibiotics at the time of registration
See the full eligibility criteria
- 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)
- History and physical examination by treating physician (head and neck surgeon and radiation oncologist) within 28 days prior registration
- The patient must be expected to withstand both study interventions
- The patient must have undergone panendoscopy with assessment for the feasibility of transoral exposure for resection. Patients without feasible exposure are not eligible
- 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...
- 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
- 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...
- Written informed consent, signed by the patient and the investigator.
- 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...
- Co-existing disease prejudicing survival (expected survival less than 6 months)
- Active bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- History of any voice disorders (not related to the SCCGL) lasting longer than 3 weeks
- Illness requiring hospitalization or precluding study therapy within 28 days before registration
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
- Mumbai, Maharashtra, India
- Bern, Canton of Bern, Switzerland
- Zurich, Canton of Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France; Mumbai, Maharashtra, India; Bern, Canton of Bern, Switzerland; Zurich, Canton of Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.