NCT03548285 is a NA clinical trial of Radiation therapy in Glottic Carcinoma, sponsored by University of Texas Southwestern Medical Center.

Who is sponsoring NCT03548285?

NCT03548285 is sponsored by University of Texas Southwestern Medical Center.

What drugs are being tested in NCT03548285?

Interventions in NCT03548285: Radiation therapy.

What condition does NCT03548285 study?

NCT03548285 studies Glottic Carcinoma.

Is NCT03548285 still recruiting?

NCT03548285 is currently completed. Last updated 22 May 2025.

Are results published for NCT03548285?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-05-22 · How we verify

NCT03548285

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer

Completed NA Results posted Last updated 22 May 2025

What this trial tests

NA trial testing Radiation therapy in Glottic Carcinoma in 25 participants. Completed in 30 April 2024.

Timeline

15 May 2018

Primary endpoint
25 April 2023

30 April 2024

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	15 May 2018
Primary completion	25 April 2023
Estimated completion	30 April 2024
Sites	1 location across United States

Drugs / interventions tested

Radiation therapy — full drug profile →

Conditions studied

Glottic Carcinoma — all drugs for Glottic Carcinoma →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 120, any sex, with Glottic Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Local Failure Following SABR Treatment of Early Glottic Larynx Cancers Primary · 2 years

Local failure is defined as biopsy-proven tumor anywhere on the true vocal cords.

Group	Value	95% CI
All Patients	2

Voice-quality Score Following Treatment With SABR Secondary · From baseline to 2 years post-treatment

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

Group	Value	95% CI
1M Follow up	28.5	8 – 48
6M Follow up	4	0 – 12
12M Follow up	7.5	0 – 12
24M Follow Up	7.5	0 – 12
Baseline	57	32 – 69

Number of Patients With Grade 3-5 Acute and Late Toxicities Following Treatment With SABR Secondary · 90 days, 3 years

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.

Acute

Group	Value	95% CI
All Patients	6

Late

Group	Value	95% CI
All Patients	19

Health-related Quality of Life Following Treatment With SABR. Secondary · From baseline to 2 years post-treatment

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.

Baseline

Group	Value	95% CI
Patients Receiving SBRT Treatment	78	0 – 100

6 Months

Group	Value	95% CI
Patients Receiving SBRT Treatment	86.2	0 – 100

12 Months

Group	Value	95% CI
Patients Receiving SBRT Treatment	83.2	0 – 100

24 Months

Group	Value	95% CI
Patients Receiving SBRT Treatment	85.5	0 – 100

Percentage of Participants With Locoregional Failure Following SABR With Death as a Competing Risk Secondary · 2 years

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.

2 Years

Group	Value	95% CI
All Patients	8	3 – 24

1 Year

Group	Value	95% CI
All Patients	4	0.8 – 20

Overall Survival Secondary · 2 years

Overall survival

Passed

Group	Value	95% CI
All Patients	4

Survival

Group	Value	95% CI
All Patients	21

Percentage of Patient Population With Regional Failure and Distant Metastasis Secondary · 2 years

With death and prior locoregional failure as competing risks

2-year regional recurrence

Group	Value	95% CI
All Patients	8

2-year distant metastasis

Group	Value	95% CI
All Patients	8

Laryngectomy-free Survival Secondary · 2 years

Laryngectomy-free survival probability at 2 years

Group	Value	95% CI
All Patients	88

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline to 36M post treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Patients

Serious: 2/25 (8%)

Deaths: 4/25

Serious adverse events (13 terms)

Reaction	System	All Patients
Hyponatremia	Metabolism and nutrition disorders	—
Acute kidney injury	Renal and urinary disorders	—
Aspiration	Respiratory, thoracic and mediastinal disorders	—
Chronic kidney disease	Renal and urinary disorders	—
Dehydration	Metabolism and nutrition disorders	—
Dysphagia	Gastrointestinal disorders	—
Gastroenteritis	Gastrointestinal disorders	—
Hypoglycemia	Metabolism and nutrition disorders	—
INR Increased	Investigations	—
Lung infection	Infections and infestations	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—
Hypoxic respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Skin infection	Infections and infestations	—

Other adverse events (83 terms — click to expand)

Reaction	System	All Patients
Hypertension	Vascular disorders	—
Hoarseness	Respiratory, thoracic and mediastinal disorders	—
Sore throat	Respiratory, thoracic and mediastinal disorders	—
Dry mouth	Gastrointestinal disorders	—
Fatigue	General disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Dysgeusia	Nervous system disorders	—
constipation	Gastrointestinal disorders	—
Dysphagia	Gastrointestinal disorders	—
Odynophagia	Gastrointestinal disorders	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	—
Edema limb	General disorders	—
Covid-19	Infections and infestations	—
Laryngeal edema	Respiratory, thoracic and mediastinal disorders	—
Laryngeal mucositis	Respiratory, thoracic and mediastinal disorders	—
Mucositis oral	Gastrointestinal disorders	—
Weight loss	Investigations	—
Ear pain	Ear and labyrinth disorders	—
Voice alteration	Respiratory, thoracic and mediastinal disorders	—
Bradycardia	Cardiac disorders	—
Dermatitis radiation	Injury, poisoning and procedural complications	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Headaches	Nervous system disorders	—
oral thrush	Infections and infestations	—
hip pain	Musculoskeletal and connective tissue disorders	—
nausea	Gastrointestinal disorders	—
neck pain	Musculoskeletal and connective tissue disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Postnasal drip	Respiratory, thoracic and mediastinal disorders	—
Abdominal pain	Gastrointestinal disorders	—
Anorexia	Metabolism and nutrition disorders	—
Anxiety	Psychiatric disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Atrial flutter	Cardiac disorders	—
Blurred vision	Eye disorders	—
Bronchial infection	Infections and infestations	—
Creatinine increased	Investigations	—
Depression	Psychiatric disorders	—
diarrhea	Gastrointestinal disorders	—

Most-reported serious reactions: Hyponatremia, Acute kidney injury, Aspiration, Chronic kidney disease, Dehydration, Dysphagia, Gastroenteritis, Hypoglycemia.

Data from ClinicalTrials.gov NCT03548285 adverse events section.

Sponsor's own description

This is a prospective study to determine the local control and quality-of-life outcomes of using SBRT for early-stage glottic larynx cancer.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging Concepts and Novel Strategies in Radiation Therapy for Laryngeal Cancer Management.
Gamez ME, Blakaj A, Zoller W, Bonomi M, et al · · 2020 · cited 23× · PMID 32580375 · DOI 10.3390/cancers12061651
Benchmarking techniques for stereotactic body radiotherapy for early-stage glottic laryngeal cancer: LINAC-based non-coplanar VMAT vs. Cyberknife planning.
Zhang Y, Chiu T, Dubas J, Tian Z, et al · · 2019 · cited 11× · PMID 31684993 · DOI 10.1186/s13014-019-1404-z
The Evolving Role of Stereotactic Body Radiation Therapy for Head and Neck Cancer: Where Do We Stand?
Mohamad I, Karam I, El-Sehemy A, Abu-Gheida I, et al · · 2023 · cited 9× · PMID 37894377 · DOI 10.3390/cancers15205010

Verify or expand the search:

Other trials of Radiation therapy

Trials testing the same drug.

NCT06990061 — Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer: an Open-label, Single-arm, · NA · not yet recruiting
NCT06831526 — Neoadjuvant Chemoradiotherapy With or Without Concurrent Azeliragon in Patients With Newly Diagnosed Glioblastoma · EARLY_PHASE1 · recruiting
NCT05608369 — Vorinostat in Combination With Chemoradiation in Locally Advanced HPV Negative HNSCC · Phase 2 · withdrawn
NCT06702033 — The Minimalist Trial-2 · Phase 2 · recruiting
NCT06583070 — SABR Combined With Targeted Therapy and Anti-PD-1 for Recurrent or Metastatic Renal Cancer · recruiting

Other recruiting trials for Glottic Carcinoma

Currently open trials in the same condition.

NCT04908696 — Clinical Treatments in Specialized Diseases of Laryngeal Carcinoma (LC) and Hypopharyngeal Carcinoma (HPC) · recruiting
NCT05688488 — Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords · Phase 1, PHASE2 · recruiting

Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

NCT03849963 — Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain · recruiting
NCT06917183 — Developing Strategies for Implementation and Use of the Operating Room Black Box (ORBB) · NA · not yet recruiting
NCT05145309 — Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans · Phase 2 · not yet recruiting
NCT06552000 — Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer · NA · not yet recruiting
NCT07387666 — Imaging Acetadote Metabolism in Glioblastoma · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03548285 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 22 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03548285.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing