Clinical trial NCT04778306: Transoral Laser Surgery and Radiotheraphy for Early Stage Laryngeal Squamous Cell Cancer
Official title: Comparision of Oncological Results of Transoral Laser Surgery and Radiotheraphy for Early Stage Laryngeal Squamous Cell Cancer: Single Center Median Long-term Results.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Larynx Cancer
Keywords: Early stage laryngeal cancer
Oncological results
Squamous cell laryngeal cancer
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 261
Sex: ALL
Minimum age (years): 33
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Early stage laryngeal cancer (Tis-1-2N0M0)
* \>18 years old.

Exclusion Criteria:

* \<18 years old
* History of another malignant disease
* Incomplete data
* Non-squamous cell carcinoma
* No follow-up.

Primary outcomes:
measure: Overall survival
timeFrame: at least 1 year
Secondary outcomes:
Other outcomes:
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