TALC (Treatment of Advanced Laryngeal Cancer) Study

The TALC study has been developed to improve the understanding and care of patients with laryngeal cancer. For many patients with cancer of the voice box, chemotherapy and radiation therapy frequently allow doctors to save voice boxes without sacrificing survival. However, we do not have full understanding of how these treatments affect a patient's quality of life, swallowing and voice.

The TALC study is an observational multi-site study assessing how chemoradiation vs laryngectomy impacts quality of life, in particular, swallowing and speech. The focus will be evaluating the impact of chemoradiation and laryngectomy on patients with new tumors of the hypopharynx (T2, T3) and cartilage-invading larynx (T3, T4) that would require total laryngectomy for cure. This is a joint AHNS/AAO-HNS study with a sample size goal of n=220. Data will be collected from both physician and patients using an online data portal developed at the UMN. Reminder emails are sent at appropriate follow-up periods. TALC is now approved through the UMN IRB and the UMN Cancer Center and ready to start recruiting sites and working through their IRBs.

Goals:

• to identify pre-treatment predictors of swallowing function after treatment
• to explore the relative impact of chemoradiation vs. laryngectomy on swallowing, with secondary analyses of outcomes such as self-reported health status, H&N-specific function, and speech.

Background:

In the past patients diagnosed with advanced squamous cancer of the larynx (T3, T4) and hypopharynx (T2, T3) were treated surgically with a total laryngectomy (including removal of the voice box) with a curative intent. However with advances in chemotherapy and radiation therapy and the publication of two landmark papers demonstrating equivalent survival with substantial rates of laryngeal preservation, chemoradiation has become standard of care at many centers. With the increased use of chemoradiation, an assumption has been made that laryngeal preservation leads to improved quality of life. Yet this association has not yet been substantiated and recent data suggest that this assumption may be flawed. Reports of dysphagia, stricture, and aspiration after chemoradiation secondary to severe fibrosis suggest that preservation of the larynx does not ensure good function

Patient Inclusion Criteria:

• Newly diagnosed squamous cell carcinoma of the larynx (cartilage invading-T3 and all T4) or hypopharynx (T2 and T3)
• 18 years of age or older
• Willingness and ability to complete self-administered follow-up questionnaires over the course of one year
• Voluntary written informed consent

Patient Exclusion Criteria:

• Require a resection that would involve more than the standard laryngectomy
• Undergo partial laryngectomy, whether open or endoscopic
• Have previously altered anatomy of the upper aerodigestive tract
• Have pre-existing dysphagia unrelated to the tumor, or neurologic disorders that could affect swallowing (Parkinson’s, cerebrovascular accidents)
• Have prior malignant disease of the upper aerodigestive tract
• Have prior radiation therapy to the head and neck region
• Known metastatic disease
• Unable to complete self-administered questionnaires written in simple English

Principal Investigator:

Bevan Yueh, MD MPH
University of Minnesota
Dept of OTO-HNS
420 Delaware St SE MMC396
Minneapolis, MN 55455
byueh@umn.edu

Co Investigator:                                   

Jonas T Johnson, MD
Professor and Chairman
The Eye & Ear Inst Bldg
Dept of Otolaryngology
200 Lothrop St Ste 500
Pittsburgh, PA 15213-2546
johnsonjt@upmc.edu

Participating sites:

• Duke University
• Emory University
• Johns Hopkins University
• Mayo Clinic Arizona
• MD Anderson Cancer Center
• Medical University of South Carolina - Hollings Cancer Center
• Memorial Sloan-Kettering Cancer Center
• Oregon Health & Science University
• St. Louis University
• University of California, SF
• University of Illinois at Chicago
• University of Iowa
• University of Kansas Medical Center
• University of Kentucky
• University of Miami Miller School of Medicine
• University of Michigan
• University of Minnesota
• University of Missouri
• University of Nebraska
• University of North Carolina
• University of Oklahoma
• University of Pittsburgh
• University of South Dakota
• University of Washington

To learn more visit https://talc.msi.umn.edu/ or contact Patricia Fernandes, the study coordinator, at ferna079@umn.edu.