Glottic CarcinomaNCT03548285
Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer
A study testing Radiation therapy in people with Glottic Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a prospective study to determine the local control and quality-of-life outcomes of using SBRT for early-stage glottic larynx cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Glottic Carcinoma
- What is being tested?
- Radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically-proven diagnosis of squamous cell carcinoma in situ, squamous cell carcinoma or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the glottic larynx.
- Clinical stage I-II (American Joint Committee on Cancer AJCC, 7th edition) with direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer and PET/CT or CT neck showing no evidence of regional disease.
- Age ≥ 18 years.
- ECOG Performance Status 0-2
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- 5.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
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- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
- Ability to understand and the willingness to sign a written informed consent.
- Patients with cognitive impairment or other limited decision making capacity with the ability to understand and willingly sign written informed consent or have the consent signed by a designated legally authorized representative (LAR)
Who cannot join
- AJCC stage III or stage IV larynx cancer
- Involvement of the arytenoid cartilage beyond the vocal process.
- Prior chemotherapy for treatment of the targeted larynx lesion
- Synchronous primaries in the head and neck
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
- Subjects smoking in excess of 1 pack of cigarettes per day.
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- Subjects may not be receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: A Phase II Study of Glottic Larynx Stereotactic Ablative Radiotherapy (LT-SABR) for Early-Stage Glottic Larynx Cancer
This is a prospective study to determine the local control and quality-of-life outcomes of using SBRT for early-stage glottic larynx cancer.
Read the detailed description
SBRT treatment will be delivered to patients diagnosed with stage I-II glottic larynx cancer twice per week for 5 fractions (42.5 Gy cohort, low-risk) or daily for 16 fractions (58.08 Gy cohort, moderate-risk).
Low-risk is defined by:
- Planning target volume (PTV) less than 10 cc, AND
- No reported smoking within 1 month from registration
Moderate-risk is defined by:
- Planning target volume (PTV) greater than or equal to 10 cc, OR
- Smoking within 1 month from registration (no more than 1 pack per day)
- Conditions
- Glottic Carcinoma
- Being tested
- Radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT)
| Study group | Role | What they receive |
|---|---|---|
| SBRT Treatment | Experimental | Patients are all treated with stereotactic body radiation therapy (SBRT), using either CyberKnife or volumetric modulated arc therapy (VMAT). Dosing is based on the patients' assessed risk. The two cohorts are low risk and moderate risk.
Low-risk is defined by:
* Planning target volume (PTV) less than 10 cc, AND
* No reported smoking within 1 month from registration
Radiation Therapy will be delivered twice per week for 5 fractions (total 42.5 Gy)- this provides both an adequate tumoricidal dose, and a limited dose to normal tissue.
Moderate-risk is defined by:
* Planning target volume (PTV) greater than or equal to 10 cc, OR
* Smoking within 1 month from registration (no more than 1 pack per day)
Radiation Therapy will be delivered daily for 16 fraction (total 58.08 Gy) Receives: Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Local Failure Following SABR Treatment of Early Glottic Larynx Cancers
Local failure is defined as biopsy-proven tumor anywhere on the true vocal cords.
Measured: 2 years
Secondary outcomes (7)
Voice-quality Score Following Treatment With SABR
Voice Handicap Index (VHI) voice-quality score to monitor changes in self-perception of voice handicap before and after treatment.
0-30 Mild Minimal amount of handicap 31-60 Moderate handicap 60-120 Severe handicap
Measured: From baseline to 2 years post-treatment
Number of Patients With Grade 3-5 Acute and Late Toxicities Following Treatment With SABR
Number of patients with grade 3-5 acute (start of treatment through 90 days from the completion of treatment) and late (after 90 days from the completion of treatment) adverse events, according to NCI's Common Terminology Criteria for Adverse Events (CTCAE) v4.0 toxicity criteria.
Measured: 90 days, 3 years
Health-related Quality of Life Following Treatment With SABR.
Average patient visual analogue scale score (derived from EQ-5D) at baseline, 6, 12, and 24 months from the end of treatment
The Visual Analogue Score (VAS) of the EQ-5D is a visual scale from 0-100, with 100 being perfect health, where patients can mark their perceived health. Researchers can then take the average score across all patients for each timepoint.
Measured: From baseline to 2 years post-treatment
Percentage of Participants With Locoregional Failure Following SABR With Death as a Competing Risk
Specifically, the 2-year cumulative risk of biopsy-proven recurrence anywhere in the larynx or neck following SABR. Recurrence in this context includes biopsy-proven cancer anywhere in the supraglottic, glottic, or subglottic larynx, as well as any malignant lymph node in the cervical or supraclavicular lymph nodes.
Measured: 2 years
Overall Survival
Overall survival
Measured: 2 years
Percentage of Patient Population With Regional Failure and Distant Metastasis
With death and prior locoregional failure as competing risks
Measured: 2 years
Laryngectomy-free Survival
Laryngectomy-free survival probability at 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start15 May 2018
- Primary completion25 Apr 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glottic CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Sher, University of Texas Southwestern Medical Center
- Investigators
- David Sher, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548285
- Sponsor's protocol ID
- STU 122017-043
- Status last verified
- May 2025
- First submitted
- 3 May 2018
- Last updated
- 22 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Zhao B, Park YK, Gu X, Reynolds R, Timmerman R, Sher DJ. Surface guided motion management in glottic larynx stereotactic body radiation therapy. Radiother Oncol. 2020 Dec;153:236-242. doi: 10.1016/j.radonc.2020.08.027. Epub 2020 Sep 3.
PubMed 32890609
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Glottic Larynx Stereotactic Ablative Radiotherapy (LT-SABR) for Early-Stage Glottic Larynx Cancer
- ClinicalTrials.gov ID
- NCT03548285
- Acronym / sponsor ID
- STU 122017-043
- Conditions
- Glottic Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 7 Jun 2018 (actual)
- Results
- Posted 25 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective study to determine the local control and quality-of-life outcomes of using SBRT for early-stage glottic larynx cancer.
Detailed description
SBRT treatment will be delivered to patients diagnosed with stage I-II glottic larynx cancer twice per week for 5 fractions (42.5 Gy cohort, low-risk) or daily for 16 fractions (58.08 Gy cohort, moderate-risk).
Low-risk is defined by:
- Planning target volume (PTV) less than 10 cc, AND
- No reported smoking within 1 month from registration
Moderate-risk is defined by:
- Planning target volume (PTV) greater than or equal to 10 cc, OR
- Smoking within 1 month from registration (no more than 1 pack per day)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT Treatment | Experimental | Radiation: Radiation therapyPatients are all treated with stereotactic body radiation therapy (SBRT), using either CyberKnife or volumetric modulated arc therapy (VMAT). Dosing is based on the patients' assessed risk. The two cohorts are low risk and moderate risk. Low-risk is defined by: * Planning target volume (PTV) less than 10 cc, AND * No reported smoking within 1 month from registration Radiation Therapy will be delivered twice per week for 5 fractions (total 42.5 Gy)- this provides both an adequate tumoricidal dose, and a limited dose to normal tissue. Moderate-risk is defined by: * Planning target volume (PTV) greater than or equal to 10 cc, OR * Smoking within 1 month from registration (no more than 1 pack per day) Radiation Therapy will be delivered daily for 16 fraction (total 58.08 Gy) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically-proven diagnosis of squamous cell carcinoma in situ, squamous cell carcinoma or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the glottic larynx.
- Clinical stage I-II (American Joint Committee on Cancer AJCC, 7th edition) with direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer and PET/CT or CT neck showing no evidence of regional disease.
- Age ≥ 18 years.
- ECOG Performance Status 0-2
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Key exclusion criteria (9 listed)
- AJCC stage III or stage IV larynx cancer
- Involvement of the arytenoid cartilage beyond the vocal process.
- Prior chemotherapy for treatment of the targeted larynx lesion
- Synchronous primaries in the head and neck
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
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 |
|---|---|---|
| Radiation therapyStereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT) | Radiation | SBRT Treatment |
Primary outcome
Number of Patients With Local Failure Following SABR Treatment of Early Glottic Larynx Cancers
Time frame: 2 years
Local failure is defined as biopsy-proven tumor anywhere on the true vocal cords.
7 secondary outcomes
Voice-quality Score Following Treatment With SABR
Time frame: From baseline to 2 years post-treatment
Number of Patients With Grade 3-5 Acute and Late Toxicities Following Treatment With SABR
Time frame: 90 days, 3 years
Health-related Quality of Life Following Treatment With SABR.
Time frame: From baseline to 2 years post-treatment
Percentage of Participants With Locoregional Failure Following SABR With Death as a Competing Risk
Time frame: 2 years
Overall Survival
Time frame: 2 years
Percentage of Patient Population With Regional Failure and Distant Metastasis
Time frame: 2 years
Laryngectomy-free Survival
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32890609Zhao B, Park YK, Gu X, Reynolds R, Timmerman R, Sher DJ. Surface guided motion management in glottic larynx stereotactic body radiation therapy. Radiother Oncol. 2020 Dec;153:236-242. doi: 10.1016/j.radonc.2020.08.027. Epub 2020 Sep 3.
Related trials for Glottic Carcinoma
Not yet recruitingPhase 2
Volumetric Adaptive SBRT Versus Conventional Accelerated Radiation Therapy for Early-Stage Glottic Cancer
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Recruiting
Role of Postoperative Radiotherapy in T1-T2N0M0 Glottic Carcinoma Involving the Anterior Commissure
Early Stage Glottic Squamous Cell Carcinoma Involving the Anterior Commissure
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Role of Radiotherapy in T1-T2N0M0 Glottic Carcinoma With Poor Differentiation
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Precision Medicine: MRI-Guided Stereotactic Ablative Radiotherapy (MRI-SABR) for Early-Stage Glottic Laryngeal Cancer
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RecruitingObservational study
Clinical Treatments in Specialized Diseases of Laryngeal Carcinoma (LC) and Hypopharyngeal Carcinoma (HPC)
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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.
David Sher, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation therapy in people with Glottic Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 11 inclusion and 9 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 22 May 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Local Failure Following SABR Treatment of Early Glottic Larynx Cancers (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03548285, which also lists 1 linked publication.
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 22 May 2025.