Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04778306 |
| Other study ID # |
SBUADYBTRH |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2010 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
February 2021 |
| Source |
Saglik Bilimleri Universitesi |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: The investigators aimed to compare the oncological results of patients with early
stage laryngeal squamous cell carcinoma (LSCC) treated with Transoral Laryngeal Surgery
(TOLS) and Radiotheraphy (RT).
Methods: The patients were divided into two groups as TOLS (Group 1) and RT (Group 2)
according to the treatment method. Both groups were compared with each other in terms of
local recurrence, regional recurrence, distant metastasis, 3 and 5-year overall survival,
disease-free survival, disease-specific survival and laryngectomy-free survival rates.
Survival analyses was made by Kaplan Meier product limit estimation. A p-value of less than
0.05 was considered as statistically significant.
Description:
Laryngeal cancers are one of the most common head and neck cancers (HNC). According to the
2018 cancer statistics, the estimated number of new laryngeal cancer cases annually is
177.000, and approximately half of these cases died due to the laryngeal cancer. While the
most common HNC in the world is oral cavity cancer, in Turkey the most common HNC is
laryngeal cancer. In Turkey, laryngeal cancers are showed 6.6/ 100.000 in men, 0.5/ 100.000
in women, and it ranked eighth in cancer deaths in men. Every year in Turkey, more than 3500
cases of new laryngeal cancer are expected, and its incidence has increased significantly in
the last ten years.
In the main treatment of early stage laryngeal cancers, surgery (transoral laryngeal surgery
(TOLS) - open partial laryngeal surgery (OPLS)) and radiotherapy (RT) are used. Although the
oncological results of all of three treatment strategies are similar, TOLS performed with
laser is preferred mostly because of short hospital stay, low cost, good functional result,
low morbidity and mortality.
There are quite different studies in the literature on whether surgical and non-surgical
treatment methods used in the treatment of early stage laryngeal cancers are superior to each
other in terms of oncological results. In a randomized controlled study with a large patient
series comparing surgery and radiotherapy, 5-year overall survival (OS) in T1 tumors (91.7%
in the RT group, 100% in the surgery group) and in T2 tumors (88.8% in the RT group, 97.4% in
the surgery group) was similar. 5-year disease-free survival (DFS) in T2 tumors (60.1% in RT
group, 78.7% in surgery group) was higher in favor of surgery. Studies comparing TOLS and
radiotheraphy in the treatment of early stage laryngeal cancer within the last 20 years have
reported comparable oncologic outcomes; two recent meta-analyses have reported better overall
survival after TOLS than radiotheraphy, despite being able to show any difference in local
control. In this study, we aimed to compare the effects of TOLS and RT on local control,
regional control, overall survival (OS), disease-free survival (DFS), disease-specific
survival (DSS) and larynjectomy-free survival (LFS) in early stage laryngeal cancers in our
own series of patients with high patient volume and long follow-up.
