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

Primary Purpose

Larynx Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transoral Laser Surgery
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Larynx Cancer focused on measuring Early stage laryngeal cancer, Oncological results, Squamous cell laryngeal cancer

Eligibility Criteria

33 Years - 83 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Trans Oral Laser Surgery (Group 1)

    Radiotherapy (Group 2).

    Arm Description

    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.

    . 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.

    Outcomes

    Primary Outcome Measures

    Overall survival
    Overall survival

    Secondary Outcome Measures

    Full Information

    First Posted
    February 21, 2021
    Last Updated
    February 27, 2021
    Sponsor
    Saglik Bilimleri Universitesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04778306
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2010 (Actual)
    Primary Completion Date
    December 31, 2019 (Actual)
    Study Completion Date
    December 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Saglik Bilimleri Universitesi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Larynx Cancer
    Keywords
    Early stage laryngeal cancer, Oncological results, Squamous cell laryngeal cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    261 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Trans Oral Laser Surgery (Group 1)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Radiotherapy (Group 2).
    Arm Type
    Active Comparator
    Arm Description
    . 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Transoral Laser Surgery
    Intervention Description
    Remove of the laryngeal tumour via diode laser
    Primary Outcome Measure Information:
    Title
    Overall survival
    Description
    Overall survival
    Time Frame
    at least 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    33 Years
    Maximum Age & Unit of Time
    83 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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