Clinical trial · Interventional
Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
A Randomized Study of Vocal-cord Only vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicentrer, randomized Bayesian Phase II trial for patients with early stage (T1N0) glottic squamous cell carcinoma treated with radical radiotherapy. The primary objective is to assess the non-inferiority of local control achieved with vocal-cord only radiotherapy (VC-RT) compared to complete larynx radiotherapy (CL-RT) in T1N0 glottic laryngeal squamous cell cancer, measured at 2-years after treatment. Secondary outcomes include overall survival, as well as voice impairment, dysphagia and quality of life, measured respectively by the voice handicap index -10 (VHI-10), the MD Anderson Dysphagia Inventory (MDADI) and the MD Anderson Symptom Inventory- Head and Neck module (MDASI-HN). Patients will be randomized in a 1:3 ratio to CL-RT (39 patients) and VC-RT (116 patients) arms. There will be stratification by tumor stage (T1a/T1b) and by institution. An interim analysis is planned after the first 55 patients enrolled on the experimental arm have a 6-month follow-up.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Neck | — | UNRESOLVED | — |
| Glottis Tumor | Glottis Neoplasm | ALIAS | 0.90 |
| Larynx Cancer | Malignant Laryngeal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Complete Larynx Radiotherapy | Radiation | — | UNRESOLVED |
| Vocal-cord Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vocal-cord Radiotherapy
- interventionNames
- Radiation: Vocal-cord Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Complete Larynx Radiotherapy
- interventionNames
- Radiation: Complete Larynx Radiotherapy
Primary outcomes (1)
- measure
- Local control
- timeFrame
- At 2-year follow-up
- description
- Local control rate of vocal-cord radiotherapy
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage T1a-b N0 of the true vocal cords planned for definitive RT * Patient not candidate for laser surgery or declined laser surgery * Biopsy-confirmed squamous cell carcinoma, including verrucous carcinoma * Eastern Cooperative Oncology Group performance status 0-2 * Ability to provide written informed consent. Exclusion Criteria: * Previous irradiation of the head and neck (HNC) region * Pregnancy or breastfeeding * Any medical condition that represents, in the opinion of the investigator, a contraindication to radiotherapy or would prevent follow-up after radiotherapy. * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years.
References
Publications (1)
- DERIVEDBahig H, Rosenthal DI, Nguyen-Tan FP, Fuller DC, Yuan Y, Hutcheson KA, Christopoulos A, Nichols AC, Fung K, Ballivy O, Filion E, Ng SP, Lambert L, Dorth J, Hu KS, Palma D. Vocal-cord Only vs. Complete Laryngeal radiation (VOCAL): a randomized multicentric Bayesian phase II trial. BMC Cancer. 2021 Apr 22;21(1):446. doi: 10.1186/s12885-021-08195-8. PMID 33888069