Laryngeal NeoplasmSMART - 1_1NCT07391345
Precision Medicine: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) for Early-Stage Glottic Laryngeal Cancer
A study testing Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization), VMAT radiotherapy and MRI-SABR in people with Laryngeal Neoplasm and Glottic Carcinoma, run by Viktoras Rudzianskas at 1 site in Lithuania.
Trial summary
This randomized phase III trial will compare the outcomes of three treatment modalities for early-stage glottic laryngeal cancer (T1-T2N0): transoral CO₂ laser microsurgery (TLM), volumetric modulated arc therapy (VMAT), and MRI-guided stereotactic ablative radiotherapy (MRI-SABR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Neoplasm, Glottic Carcinoma
- What is being tested?
- Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization), VMAT radiotherapy and MRI-SABR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Sep 2024to Mar 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Histologically confirmed squamous cell carcinoma of the glottic larynx, including verrucous carcinoma.
- Stage T1-T2N0 (8th TNM edition).
- ECOG performance status 0-2.
- Able to understand Lithuanian and complete questionnaires.
- Signed informed consent.
Who cannot join
- AJCC stage III-IV laryngeal cancer.
- Prior radiotherapy for head and neck cancer.
- Pregnancy or breastfeeding.
- Contraindications for radiotherapy or inability to follow-up.
- Presence of another active malignancy.
- Uncontrolled intercurrent illness (e.g., active infection, symptomatic CHF, unstable angina, clinically significant arrhythmia) or any condition that would preclude radiotherapy or adequate follow-up per investigator judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site, 1 recruiting
- Recruiting
Lithuanian University of Health Sciences Kaunas Clinics
Kaunas
Vita Simonyte-Verbickiene, +37067140693, vita.simonyte-verbickiene@kaunoklinikos.lt
About this study
Official title: A Prospective, Randomized, Three-Arm, Open-Label Clinical Trial Comparing Transoral CO₂ Laser Microsurgery, Volumetric Modulated Arc Therapy (VMAT), and MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) in the Treatment of Early-Stage Glottic Laryngeal Cancer
This randomized phase III trial will compare the outcomes of three treatment modalities for early-stage glottic laryngeal cancer (T1-T2N0): transoral CO₂ laser microsurgery (TLM), volumetric modulated arc therapy (VMAT), and MRI-guided stereotactic ablative radiotherapy (MRI-SABR). The primary endpoint is local control (LC). Secondary endpoints include laryngectomy-free survival (LFS), progression-free survival (PFS). overall survival (OS), functional voice, swallowing and breathing outcomes, treatment-related complications, and the evaluation of radiomic and dosiomic biomarkers. Patients will be randomized in a 1:1:1 ratio. Total planned enrollment is 105.
- Conditions
- Laryngeal Neoplasm, Glottic Carcinoma
- Being tested
- Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization), VMAT radiotherapy, MRI-SABR
- Keywords
- Early-stage glottic laryngeal cancer, transoral laser microsurgery, VMAT, MRI-SABR, stereotactic radiotherapy, radiomics, dosiomics
- 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 CO₂ laser cordectomy (Type I-VI depending on tumor localization)Procedure or surgery
Surgical removal of the tumor with at least 2 mm margins; intraoperative frozen section biopsies; short hospitalization (1-3 days).
VMAT radiotherapyRadiation
Accelerated fractionation schedule: T1N0 - 63 Gy/28 fractions; T2N0 - 65.25 Gy/29 fractions; delivered using Eclipse planning system.
MRI-SABRRadiation
42.5 Gy total dose in 5 fractions, 2 fractions per week, planned with CT and MRI simulation and delivered with MRI-LINAC system.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Transoral CO₂ Laser Microsurgery (TLM) | Active comparator | Participants undergo transoral CO₂ laser microsurgery for the treatment of early-stage glottic laryngeal cancer. Receives: Procedure: Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization) |
| Arm B: Volumetric Modulated Arc Therapy (VMAT) | Active comparator | Participants receive definitive external beam radiotherapy using volumetric modulated arc therapy. Receives: Radiation: VMAT radiotherapy |
| Arm C: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) | Active comparator | Participants receive definitive MRI-guided stereotactic ablative radiotherapy. Receives: Radiation: MRI-SABR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tumor Control Rate Assessed by Endoscopy and Imaging
Proportion of participants without local tumor recurrence, assessed by laryngoscopic examination and radiological imaging.
Measured: At 2 years after completion of treatment; At 5 years after completion of treatment
Secondary outcomes (8)
Laryngectomy-Free Survival (LFS)
Time from randomization to total laryngectomy or death from any cause, whichever occurs first.
Measured: Up to 2 years after randomization; Up to 5 years after randomization
Progression-Free Survival (PFS)
Time from randomization to disease progression (local, regional, or distant) or death from any cause, whichever occurs first.
Measured: Up to 2 years after randomization; Up to 5 years after randomization
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: Up to 2 years after randomization; Up to 5 years after randomization
Objective Voice Parameters Assessed by Acoustic Analysis (lingWAVES)
Objective voice parameters derived from acoustic signal analysis using the lingWAVES system.
Measured: Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment
Patient-Reported Voice Outcome Assessed by Voice Screen Application
Patient-reported voice outcome assessed using the Voice Screen mobile application.
Measured: Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment
Swallowing Function Score Assessed by Anderson Dysphagia Inventory
Swallowing function assessed using the Anderson Dysphagia Inventory questionnaire (total score).
Measured: Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment
Health-Related Quality of Life Scores Assessed by EORTC QLQ-C30 and QLQ-H&N35
Health-related quality of life assessed using the EORTC QLQ-C30 and QLQ-H\&N35 questionnaires (global health status and domain scores).
Measured: Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment
Quantitative Radiomic and Dosiomic Feature Values and Their Statistical Associations With Clinical Outcomes
Quantitative radiomic feature values extracted from baseline and follow-up imaging (CT, MRI, PET/CT) and quantitative dosiomic feature values derived from radiotherapy treatment plans. Associations with clinical outcomes (local tumor control, progression-free survival, overall survival) will be summarized using correlation coefficients and hazard ratios.
Measured: From baseline imaging through 5 years after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Sep 2024
- Primary completionSep 2029 (estimated)
- Study completionMar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal NeoplasmStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viktoras Rudzianskas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Viktoras Rudzianskas, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391345
- Sponsor's protocol ID
- BE-2-45
- Acronym
- SMART - 1_1
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Three-Arm, Open-Label Clinical Trial Comparing Transoral CO₂ Laser Microsurgery, Volumetric Modulated Arc Therapy (VMAT), and MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) in the Treatment of Early-Stage Glottic Laryngeal Cancer
- ClinicalTrials.gov ID
- NCT07391345
- Acronym / sponsor ID
- SMART - 1_1 / BE-2-45
- Conditions
- Laryngeal Neoplasm, Glottic Carcinoma
- Keywords
- Early-stage glottic laryngeal cancer, transoral laser microsurgery, VMAT, MRI-SABR, stereotactic radiotherapy, radiomics, dosiomics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Viktoras RudzianskasUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Mar 2034 (estimated)
- First posted
- 5 Feb 2026 (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.
This randomized phase III trial will compare the outcomes of three treatment modalities for early-stage glottic laryngeal cancer (T1-T2N0): transoral CO₂ laser microsurgery (TLM), volumetric modulated arc therapy (VMAT), and MRI-guided stereotactic ablative radiotherapy (MRI-SABR). The primary endpoint is local control (LC). Secondary endpoints include laryngectomy-free survival (LFS), progression-free survival (PFS). overall survival (OS), functional voice, swallowing and breathing outcomes, treatment-related complications, and the evaluation of radiomic and dosiomic biomarkers. Patients will be randomized in a 1:1:1 ratio. Total planned enrollment is 105.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Transoral CO₂ Laser Microsurgery (TLM) | Active comparator | Procedure: Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization)Participants undergo transoral CO₂ laser microsurgery for the treatment of early-stage glottic laryngeal cancer. |
| Arm B: Volumetric Modulated Arc Therapy (VMAT) | Active comparator | Radiation: VMAT radiotherapyParticipants receive definitive external beam radiotherapy using volumetric modulated arc therapy. |
| Arm C: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) | Active comparator | Radiation: MRI-SABRParticipants receive definitive MRI-guided stereotactic ablative radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Histologically confirmed squamous cell carcinoma of the glottic larynx, including verrucous carcinoma.
- Stage T1-T2N0 (8th TNM edition).
- ECOG performance status 0-2.
- Able to understand Lithuanian and complete questionnaires.
Key exclusion criteria (6 listed)
- AJCC stage III-IV laryngeal cancer.
- Prior radiotherapy for head and neck cancer.
- Pregnancy or breastfeeding.
- Contraindications for radiotherapy or inability to follow-up.
- Presence of another active malignancy.
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 CO₂ laser cordectomy (Type I-VI depending on tumor localization)Surgical removal of the tumor with at least 2 mm margins; intraoperative frozen section biopsies; short hospitalization (1-3 days). | Procedure or surgery | Arm A: Transoral CO₂ Laser Microsurgery (TLM) |
| VMAT radiotherapyAccelerated fractionation schedule: T1N0 - 63 Gy/28 fractions; T2N0 - 65.25 Gy/29 fractions; delivered using Eclipse planning system. | Radiation | Arm B: Volumetric Modulated Arc Therapy (VMAT) |
| MRI-SABR42.5 Gy total dose in 5 fractions, 2 fractions per week, planned with CT and MRI simulation and delivered with MRI-LINAC system. | Radiation | Arm C: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) |
Primary outcome
Local Tumor Control Rate Assessed by Endoscopy and Imaging
Time frame: At 2 years after completion of treatment; At 5 years after completion of treatment
Proportion of participants without local tumor recurrence, assessed by laryngoscopic examination and radiological imaging.
8 secondary outcomes
Laryngectomy-Free Survival (LFS)
Time frame: Up to 2 years after randomization; Up to 5 years after randomization
Progression-Free Survival (PFS)
Time frame: Up to 2 years after randomization; Up to 5 years after randomization
Overall Survival (OS)
Time frame: Up to 2 years after randomization; Up to 5 years after randomization
Objective Voice Parameters Assessed by Acoustic Analysis (lingWAVES)
Time frame: Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment
Patient-Reported Voice Outcome Assessed by Voice Screen Application
Time frame: Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment
Swallowing Function Score Assessed by Anderson Dysphagia Inventory
Time frame: Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment
Health-Related Quality of Life Scores Assessed by EORTC QLQ-C30 and QLQ-H&N35
Time frame: Baseline, and at 1, 3, 6, 12, 18, and 24 months after completion of treatment
Quantitative Radiomic and Dosiomic Feature Values and Their Statistical Associations With Clinical Outcomes
Time frame: From baseline imaging through 5 years after completion of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transoral CO₂ laser cordectomy (Type I-VI depending on tumor localization), VMAT radiotherapy and MRI-SABR in people with Laryngeal Neoplasm and Glottic Carcinoma, run by Viktoras Rudzianskas at 1 site in Lithuania.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viktoras Rudzianskas (+37068745515, viktoras.rudzianskas@kaunoklinikos.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Tumor Control Rate Assessed by Endoscopy and Imaging (time frame: At 2 years after completion of treatment; At 5 years after completion of treatment). 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 5 Feb 2026.