An interventional study of Radiation therapy in Glottic Carcinoma, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
This is a prospective study to determine the local control and quality-of-life outcomes of using SBRT for early-stage glottic larynx cancer.
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:
Moderate-risk is defined by:
University of Texas Southwestern Medical Center is the lead sponsor of 1,009 studies on the registry; 201 are open to participants now.
Of its 138 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
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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:
Exclusion Criteria:
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)
Radiation: Radiation therapy
Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT)
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.
Time frame: 2 years
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Overall Survival
Overall survival
Time frame: 2 years
Percentage of Patient Population With Regional Failure and Distant Metastasis
With death and prior locoregional failure as competing risks
Time frame: 2 years
Laryngectomy-free Survival
Laryngectomy-free survival probability at 2 years
Time frame: 2 years
| Milestone | Patients Receiving SBRT Treatment |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
Local failure is defined as biopsy-proven tumor anywhere on the true vocal cords.
| participants | All Patients |
|---|---|
| Number of Patients With Local Failure Following SABR Treatment of Early Glottic Larynx Cancers | 2 |
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
| score on a scale | 1M Follow up | 6M Follow up | 12M Follow up | 24M Follow Up | Baseline |
|---|---|---|---|---|---|
| Voice-quality Score Following Treatment With SABR | 28.5 (8 to 48) | 4 (0 to 12) | 7.5 (0 to 12) | 7.5 (0 to 12) | 57 (32 to 69) |
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.
| participants | All Patients |
|---|---|
| Acute | 6 |
| Late | 19 |
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.
| score on a scale | Patients Receiving SBRT Treatment |
|---|---|
| Baseline | 78 (0 to 100) |
| 6 Months | 86.2 (0 to 100) |
| 12 Months | 83.2 (0 to 100) |
| 24 Months | 85.5 (0 to 100) |
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.
| Percentage of participants | All Patients |
|---|---|
| 2 Years | 8 (3 to 24) |
| 1 Year | 4 (0.8 to 20) |
Overall survival
| patients | All Patients |
|---|---|
| Passed | 4 |
| Survival | 21 |
With death and prior locoregional failure as competing risks
| Percentage of participants | All Patients |
|---|---|
| 2-year regional recurrence | 8 |
| 2-year distant metastasis | 8 |
Laryngectomy-free survival probability at 2 years
| Percentage of patients with LFS at 2 yrs | All Patients |
|---|---|
| Laryngectomy-free Survival | 88 |
Collected over From baseline to 36M post treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Patients | 4/25 (16%) | 2/25 (8%) | 25/25 (100%) |
| Event | All Patients |
|---|---|
| HyponatremiaMetabolism and nutrition disorders | 2/25 |
| Acute kidney injuryRenal and urinary disorders | 1/25 |
| AspirationRespiratory, thoracic and mediastinal disorders | 1/25 |
| Chronic kidney diseaseRenal and urinary disorders | 1/25 |
| DehydrationMetabolism and nutrition disorders | 1/25 |
| DysphagiaGastrointestinal disorders | 1/25 |
| GastroenteritisGastrointestinal disorders | 1/25 |
| HypoglycemiaMetabolism and nutrition disorders | 1/25 |
| INR IncreasedInvestigations | 1/25 |
| Lung infectionInfections and infestations | 1/25 |
| Event | All Patients |
|---|---|
| HypertensionVascular disorders | 17/25 |
| HoarsenessRespiratory, thoracic and mediastinal disorders | 12/25 |
| Sore throatRespiratory, thoracic and mediastinal disorders | 11/25 |
| Dry mouthGastrointestinal disorders | 9/25 |
| FatigueGeneral disorders | 9/25 |
| CoughRespiratory, thoracic and mediastinal disorders | 8/25 |
| DysgeusiaNervous system disorders | 8/25 |
| constipationGastrointestinal disorders | 6/25 |
| DysphagiaGastrointestinal disorders | 6/25 |
| OdynophagiaGastrointestinal disorders | 5/25 |
Early stage larynx cancer patients receiving SBRT; additional details in participant flow
| Age, Customized(years) | Patients Receiving SBRT |
|---|---|
| Age of patients | 72 (65 to 81) |
| Sex: Female, Male(Participants) | Patients Receiving SBRT |
|---|---|
| Female | 1 |
| Male | 24 |
| Ethnicity (NIH/OMB)(Participants) | Patients Receiving SBRT |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 22 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Patients Receiving SBRT |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Smoking(participants) | Patients Receiving SBRT |
|---|---|
| None | 8 |
| Previous | 16 |
| Active | 1 |
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