Comparing voice quality after laser surgery and targeted radiotherapy for larynx cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the voice quality outcomes of two treatment modalities for early-stage larynx cancer: Transoral CO2-Laser Microsurgical Cordectomy (TLM) and Single Vocal Cord Irradiation (SVCI). Both treatments are established standards of care, but no randomized trials have previously compared their effectiveness in preserving voice quality. The study will include patients with unilateral stage 0 or I glottic larynx cancer and will assess voice quality using validated measures. The trial is being conducted across multiple institutions in Switzerland.

Why it matters

Who can join: the full rules

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

Where it's running

• Institut Gustave Roussy
  Paris, France Recruiting
• Tata Memorial Hospital Mumbai
  Mumbai, Maharashtra, India Recruiting
• Inselspital, Bern University Hospital
  Bern, Canton of Bern, Switzerland Recruiting
• University Hospital Zurich
  Zurich, Canton of Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Olgun Elicin, M.D. — Inselspital, Bern University Hospital, 3010 Bern, Switzerland
• Study coordinator: Olgun Elicin, M.D.
• Email: olgun.elicin@insel.ch
• Phone: +41 31 632 26 32

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sacituzumab govitecan plus cetuximab for recurrent or metastatic head and neck squamous cell cancer

  This trial will test whether combining sacituzumab govitecan with cetuximab works and is safe for people whose head and neck squamous cell cancer has returned or spread after prior immunotherapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07063212

• Treatment for head and neck cancer using tailored radiotherapy and ATRA

  This study is testing if a new combination of a cancer drug called ATRA with personalized radiotherapy can help people with certain types of head and neck cancer live longer and feel better.

  Recruiting at 8 sites Phase 3 Centre Leon Berard · Lyon, France and 7 other locations · NCT06706401

• Neoadjuvant treatment for laryngeal and hypopharyngeal cancer

  This study is testing a new treatment that combines immunotherapy and chemotherapy before surgery or radiation to see if it helps people with advanced laryngeal or hypopharyngeal cancer live better and longer while keeping their voice.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT06039631

• Comparing navigation support to standard care for starting radiation therapy in head and neck cancer patients

  This study is testing a new support program to help people with head and neck cancer start their radiation therapy on time compared to the usual care they receive.

  Recruiting at 4 sites Medical University of South Carolina · St Louis, Missouri and 3 other locations · NCT05793151

• Care patterns for elderly patients with head and neck cancer receiving radiotherapy

  This study is looking at how well elderly patients with advanced head and neck cancer do with radiation treatment and chemotherapy to see if it helps them live longer and stay healthier.

  Recruiting University Hospital Freiburg · Baltimore, Maryland and 17 other locations · NCT05337631

• Using MRI-guided radiation therapy for treating certain cancers

  This study is testing if using MRI to guide radiation therapy along with chemotherapy can safely and effectively treat patients with gastric and breast cancers.

  Recruiting at 2 sites Brigham and Women's Hospital · Boston, Massachusetts and 1 other locations · NCT04368702

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.