Clinical trial NCT03759431: Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
Official title: A Randomized Study of Vocal-cord Only vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cancer Neck
Larynx Cancer
Glottis Tumor
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
name: M.D. Anderson Cancer Center
First posted: 2018-11-30
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Local control
timeFrame: At 2-year follow-up
Secondary outcomes:
measure: Voice Handicap Index-10 score
timeFrame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up
measure: MD Anderson Dysphagia Inventory score
timeFrame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up
measure: MD Anderson Symptom Inventory-Head & Neck score
timeFrame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up
measure: Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
timeFrame: Week 0 post-treatment and at 6-month follow-up
measure: Rates of acute toxicity as per CTCAE v5.0
timeFrame: Week 0 post-treatment and at 2-month follow-up
measure: Rates of chronic toxicity as per CTCAE v5.0
timeFrame: At 6-month, 1-year, 2-year and 5-year post-treatment
measure: Rates of new hypothyroidism
timeFrame: At 2- and 5-year follow-up
measure: Rates of cerebrovascular event (transient ischemic attack or stroke)
timeFrame: At 5-year follow-up
measure: Overall survival
timeFrame: At 2- and 5-year follow-up
measure: Time to recurrence
timeFrame: At 2- and 5-year follow-up
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Houda Bahig
role: STUDY_CHAIR
affiliation: London Health Sciences Centre
name: David Palma
role: STUDY_CHAIR
References:
citation: 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.