NCT03548285 · REGISTRY CONDITION SEARCH

Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2025-05-22

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Patients With Local Failure Following SABR Treatment of Early Glottic Larynx Cancers

→

outcome · POSTED

Voice-quality Score Following Treatment With SABR

→

outcome · POSTED

Number of Patients With Grade 3-5 Acute and Late Toxicities Following Treatment With SABR

→

outcome · POSTED

Health-related Quality of Life Following Treatment With SABR.

→

outcome · POSTED

Percentage of Participants With Locoregional Failure Following SABR With Death as a Competing Risk

→

outcome · POSTED

Overall Survival

→

outcome · POSTED

Percentage of Patient Population With Regional Failure and Distant Metastasis

→

outcome · POSTED

Laryngectomy-free Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: 1. 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. 2. 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. 3. Age ≥ 18 years. 4. ECOG Performance Status 0-2 5. 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: * 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). 6. Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential. 7. Ability to understand and the willingness to sign a written informed consent. 8. 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) Exclusion Criteria: 1. AJCC stage III or stage IV larynx cancer 2. Involvement of the arytenoid cartilage beyond the vocal process. 3. Prior chemotherapy for treatment of the targeted larynx lesion 4. Synchronous primaries in the head and neck 5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields. 6. Subjects smoking in excess of 1 pack of cigarettes per day. 7. Subjects may not be receiving any other investigational agents. 8. 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. 9. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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)
intervention Names
Radiation: Radiation therapy
label
SBRT Treatment
type
EXPERIMENTAL

interventions

arm Group Labels
SBRT Treatment
description
Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT)
name
Radiation therapy
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 25
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Local failure is defined as biopsy-proven tumor anywhere on the true vocal cords.
measure
Number of Patients With Local Failure Following SABR Treatment of Early Glottic Larynx Cancers
time Frame
2 years

secondary Outcomes

description
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
measure
Voice-quality Score Following Treatment With SABR
time Frame
From baseline to 2 years post-treatment
description
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.
measure
Number of Patients With Grade 3-5 Acute and Late Toxicities Following Treatment With SABR
time Frame
90 days, 3 years
description
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.
measure
Health-related Quality of Life Following Treatment With SABR.
time Frame
From baseline to 2 years post-treatment
description
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.
measure
Percentage of Participants With Locoregional Failure Following SABR With Death as a Competing Risk
time Frame
2 years
description
Overall survival
measure
Overall Survival
time Frame
2 years
description
With death and prior locoregional failure as competing risks
measure
Percentage of Patient Population With Regional Failure and Distant Metastasis
time Frame
2 years
description
Laryngectomy-free survival probability at 2 years
measure
Laryngectomy-free Survival
time Frame
2 years

Full study description

brief 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.
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)

Source references

references

citation
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.
pmid
32890609
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-2337b6739b8544275288
requested nct id
NCT03548285
primary nct id
NCT03548285
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Laryngeal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
payload sha256
92d49406f12e60da45ce9e24a63834adc13957c1a12a731c193ac05c7e2a95b6
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-2337b6739b8544275288
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT03548285
occurrences
context exact
NCT03548285
end
11
exact text
NCT03548285
start
0
offset unit
unicode_code_points
query cond
Laryngeal Cancer
query disease state id
ds-laryngeal-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-laryngeal-cancer-000.json
source file sha256
fd31a95088dd8ee475e2862bffd724180f0c754cf3f0e892cba5b448df424980
source json pointer
/studies/45/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
7fe1dc0519ee2385f5392c50ddea537f7e93273c6287068a4d9ea7d52a827257
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Laryngeal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice