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 is will be collected from both physician and patients using an online data portal developed at the University of Minnesota (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 (Parkinsons, 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
Enrolled subjects as of 4/02/2014:
| Accrual to date | 271 patients |
| Mean age (years) | 60.4 |
| Gender | 208 (76.8%) Male 62 (22.9%) Female 1 Unknown |
| Treatment Group | 157 (57.9%) Surgery 113 (41.7%) Chemoradiation 1 Unknown |
Enrollment closed 12/31/2013 and one year follow-up will be completed on 12/31/2014
Principal Investigator:
Bevan Yueh, MD MPH
University of Minnesota
Dept of OTO-HNS
420 Delaware St SE MMC396
Minneapolis, MN 55455
[email protected]
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
[email protected]
Participating sites:
- University of Alabama
- University of Arkansas
- Baylor College of Medicine
- University of California Los Angeles
- University of Chicago
- Cornell University
- Dartmouth-Hitchcock Medical Center
- Duke University
- Emory University
- Henry Ford Medical Center
- University of Illinois, Chicago
- Indiana University
- University of Kansas
- University of Kentucky
- Veteran Affairs, Los Angeles
- Louisiana State University
- Mary Bird Perkins Cancer Center
- Massachusetts Eye and Ear Infirmary
- MD Anderson Cancer Center
- Memorial Sloan-Kettering Cancer Center
- University of Miami
- University of Michigan
- University of Mississippi
- University of Missouri
- University of Nebraska
- Nebraska Methodist Hospital
- University of Oklahoma
- Oregon Health & Science University
- University of Pittsburg
- Medical University of South Carolina
- Sanford Cancer Center, South Dakota
- St. Louis University
- University of Texas Medical Branch
- Thomas Jefferson University
- University Health Network, Toronto
- University of Washington
- Medical College of Wisconsin
To learn more visit https://talc.ahc.umn.edu/ or contact Patricia Fernandes, the study coordinator, at [email protected].
