Transoral Laser Surgery and Radiotheraphy for Early Stage Laryngeal Squamous Cell Cancer

NCT04778306 | Completed

• 1 other identifier: SBUADYBTRH
• Study Type: interventional
• Target: 261
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Larynx Cancer

Keywords

Early stage laryngeal cancer; Oncological results; Squamous cell laryngeal cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival

  at least 1 year

Study Arms (2)

Trans Oral Laser Surgery (Group 1)

ACTIVE COMPARATOR

In TOLS, the tumor tissue was removed en bloc and in one piece. The removed specimen was marked on a card with the help of pins. Permanent surgical margins were taken from the anterior, posterior, superior, inferior and deep areas of the tumor area.

Procedure: Transoral Laser Surgery

Radiotherapy (Group 2).

ACTIVE COMPARATOR

. In RT; the head was routinely stabilized with the help of a thermoplastic mask and subsequently covered the primary area with a size varying from 4x4 cm to 6x6 cm. Total 63-70 Gy radiotherapy was applied 2.0-2.3 Gy/ day,5 days a week, for 6-7 weeks.

Procedure: Transoral Laser Surgery

Interventions

Transoral Laser Surgery PROCEDURE

Remove of the laryngeal tumour via diode laser

Radiotherapy (Group 2).; Trans Oral Laser Surgery (Group 1)

Eligibility Criteria

• Age: 33 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: March 3, 2021
• Study Start: January 1, 2010
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share