Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer (VOCAL)

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.

Focal radiotherapy limited to the involved vocal cord(s) plus additional margins accounting for respiration and set-up errors.

Radiotherapy to the entire larynx, with target volumes defined to lead to traditional volumes from conventional complete larynx radiotherapy.

Scores are rated on a 0-4 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.

Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.

The core and head and neck cancer specific symptoms are rated on a 0-10 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.

The attributes of CAPE-V are: (a) Overall Severity; (b) Roughness; (c) Breathiness; (d) Strain; (e) Pitch; and (f) Loudness. Each attribute is displayed accompanied by a 100- millimeter line forming a visual analog scale, with a higher score representing more deviant voice attributes.

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.

Bahig 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.