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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-11

Study Completion Date

2026-12-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Neck Larynx Cancer Glottis Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vocal-cord Radiotherapy

Group Type EXPERIMENTAL

Vocal-cord Radiotherapy

Intervention Type RADIATION

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

Complete Larynx Radiotherapy

Group Type ACTIVE_COMPARATOR

Complete Larynx Radiotherapy

Intervention Type RADIATION

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

Interventions

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Vocal-cord Radiotherapy

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

Intervention Type RADIATION

Complete Larynx Radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No