Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer (VOCAL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03759431|
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : November 16, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cancer Neck Larynx Cancer Glottis Tumor||Radiation: Vocal-cord Radiotherapy Radiation: Complete Larynx Radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||155 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study of Vocal-cord Only vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer|
|Actual Study Start Date :||October 11, 2018|
|Estimated Primary Completion Date :||December 12, 2024|
|Estimated Study Completion Date :||December 12, 2024|
|Experimental: Vocal-cord Radiotherapy||
Radiation: Vocal-cord Radiotherapy
Focal radiotherapy limited to the involved vocal cord(s) plus additional margins accounting for respiration and set-up errors.
|Active Comparator: Complete Larynx Radiotherapy||
Radiation: Complete Larynx Radiotherapy
Radiotherapy to the entire larynx, with target volumes defined to lead to traditional volumes from conventional complete larynx radiotherapy.
- Local control [ Time Frame: At 2-year follow-up ]Local control rate of vocal-cord radiotherapy
- Voice Handicap Index-10 score [ Time Frame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up ]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.
- MD Anderson Dysphagia Inventory score [ Time Frame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up ]Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.
- MD Anderson Symptom Inventory-Head & Neck score [ Time Frame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up ]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.
- Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) [ Time Frame: Week 0 post-treatment and at 6-month follow-up ]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.
- Rates of acute toxicity as per CTCAE v5.0 [ Time Frame: Week 0 post-treatment and at 2-month follow-up ]
- Rates of chronic toxicity as per CTCAE v5.0 [ Time Frame: At 6-month, 1-year, 2-year and 5-year post-treatment ]
- Rates of new hypothyroidism [ Time Frame: At 2- and 5-year follow-up ]
- Rates of cerebrovascular event (transient ischemic attack or stroke) [ Time Frame: At 5-year follow-up ]
- Overall survival [ Time Frame: At 2- and 5-year follow-up ]
- Time to recurrence [ Time Frame: At 2- and 5-year follow-up ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759431
|Contact: Diane Trudel||514-890-8000 ext email@example.com|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Victoria Cox 877-832-6789 firstname.lastname@example.org|
|Principal Investigator: David I Rosenthal|
|Sub-Investigator: Clifton D Fuller|
|London Health Sciences Centre||Recruiting|
|London, Ontario, Canada, N6A 5W9|
|Contact: Patricia Moore 519-685-8500 email@example.com|
|Principal Investigator: David Palma|
|Centre Hospitalier de l'Université de Montréal||Recruiting|
|Montreal, Quebec, Canada, H2X 1R6|
|Contact: Diane Trudel 514-890-8000 ext 26906 firstname.lastname@example.org|
|Principal Investigator: Houda Bahig|
|Sub-Investigator: Phuc-Félix Nguyen-Tan|
|Study Chair:||Houda Bahig||Centre hospitalier de l'Université de Montréal (CHUM)|
|Study Chair:||David Palma||London Health Sciences Centre|
|Responsible Party:||Centre hospitalier de l'Université de Montréal (CHUM)|
|Other Study ID Numbers:||
|First Posted:||November 30, 2018 Key Record Dates|
|Last Update Posted:||November 16, 2022|
|Last Verified:||November 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||No|
Head and Neck Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms