Larynx CancerNCT04778306
Transoral Laser Surgery and Radiotheraphy for Early Stage Laryngeal Squamous Cell Cancer
A study testing Transoral Laser Surgery in people with Larynx Cancer, run by Saglik Bilimleri Universitesi.
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). Read more about this study
- Who is it for?
- Ages 33 to 83 years
- Conditions the study is for
- Larynx Cancer
- What is being tested?
- Transoral Laser Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 33 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early stage laryngeal cancer (Tis-1-2N0M0)
- >18 years old.
Who cannot join
- <18 years old
- History of another malignant disease
- Incomplete data
- Non-squamous cell carcinoma
- No follow-up.
About this study
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.
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.
Read the 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.
- Conditions
- Larynx Cancer
- Being tested
- Transoral Laser Surgery
- Keywords
- Early stage laryngeal cancer, Oncological results, Squamous cell laryngeal cancer
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral Laser SurgeryProcedure or surgery
Remove of the laryngeal tumour via diode laser
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Transoral Laser Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: at least 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Jan 2010
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Larynx CancerStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumeyra DOLUOGLU, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778306
- Sponsor's protocol ID
- SBUADYBTRH
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04778306
- Acronym / sponsor ID
- SBUADYBTRH
- Conditions
- Larynx Cancer
- Keywords
- Early stage laryngeal cancer, Oncological results, Squamous cell laryngeal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans Oral Laser Surgery (Group 1) | Active comparator | Procedure: Transoral Laser SurgeryIn 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. |
| Radiotherapy (Group 2). | Active comparator | Procedure: Transoral Laser Surgery. 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. |
Who may qualify
- Ages
- 33 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Early stage laryngeal cancer (Tis-1-2N0M0)
- >18 years old.
Key exclusion criteria (5 listed)
- <18 years old
- History of another malignant disease
- Incomplete data
- Non-squamous cell carcinoma
- No follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transoral Laser SurgeryRemove of the laryngeal tumour via diode laser | Procedure or surgery | Radiotherapy (Group 2)., Trans Oral Laser Surgery (Group 1) |
Primary outcome
Overall survival
Time frame: at least 1 year
Overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transoral Laser Surgery in people with Larynx Cancer, run by Saglik Bilimleri Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: at least 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.