Laryngeal CarcinomaG-FORCENCT06080503
Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy
A study testing LT-SABR and IMRT in people with Laryngeal Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Carcinoma
- What is being tested?
- LT-SABR and IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2024to 14 Mar 2029
- 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
- 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 0-II (AJCC, 8th 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.
- Minimum age is 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).
- Ability to understand and the willingness to sign a written informed consent.
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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Sarah Neufeld, 214-645-8525, Sarah.hardee@utsouthwestern.edu
Liliana Robles, 214-645-8525, Liliana.Robles@utsouthwestern.edu
About this study
Official title: G-FORCE: Phase II Randomized Study of Glottic Larynx Hypofractionated Radiotherapy Versus ConvEntional Radiotherapy
To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy.
Read the detailed description
Screening/Baseline Procedures Assessments performed exclusively to determine eligibility for this study will be done only after obtaining informed consent. Assessments performed for clinical indications (not exclusively to determine study eligibility) may be used for baseline values even if the studies were done before informed consent was obtained.
All screening procedures must be performed within 30 days prior to registration into the study unless otherwise stated. The screening procedures include:
Informed Consent Medical history--Complete medical and surgical history Demographics--Age, gender, race, ethnicity Review subject eligibility criteria Review previous and concomitant medications Physical exam including vital signs, height and weight Vital signs (temperature, pulse, respirations, blood pressure), height, weight Performance status--Performance status evaluated prior to study entry. If there is any variability in the physicians' notes, the higher number will be used for research purposes.
Positron emission tomography-computerized tomography or computerized tomography of neck (any time prior to registration) Laryngoscopy Pregnancy test (for females of child-bearing potential) Quality of life Questionnaires and Symptom Questionnaires --EORTC QLQ-C30, H\&N 35, VHI, and EQ-5D. These forms will be referred to collectively as QoL Questionnaires. Can be given on paper, over the phone, or in EPIC as needed.
Procedures During Treatment Day 1-First fraction of radiotherapy per standard, departmental stereotactic protocol
Follow-up Procedures--After initial follow-up at 2 weeks (+/- 7 days) after completion of radiation therapy, subjects will be followed at 3 months and 12 months. These protocol mandated procedures will occur at each follow-up:
Interim history Physical exam, vital signs, ECOG Performance Status Laryngoscopy (optional at 1-2 weeks) to assess tumor response and toxicity Quality of life and voice quality assessment. Can be given on paper, over the phone, or in EPIC as needed.
- Conditions
- Laryngeal Carcinoma
- Being tested
- LT-SABR, IMRT
- Keywords
- Larynx
- Medical subject headings
- Laryngeal Neoplasms, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT-SABRRadiation
42.5 Gy in 5 fractions Low-risk: twice/week Moderate-risk: weekly
IMRTRadiation
63 Gy in 28 fractions (T1) 65.25 Gy in 29 fractions (T2)
| Study group | Role | What they receive |
|---|---|---|
| Highly conformal hypofractionated radiotherapy | Experimental | LT-SABR 42.5 Gy in 5 fractions Low-risk: twice/week Moderate-risk: weekly Receives: Radiation: LT-SABR |
| Conventional radiotherapy | Experimental | Conventional Radiotherapy 63 Gy in 28 fractions (T1) 65.25 Gy in 29 fractions (T2) Receives: Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the acute toxicity outcomes between patients treated with highly-conformal hypofractionated radiotherapy and conventional radiotherapy.
Acute toxicity score (i.e. T score), defined as the mean number of grade 2 or higher acute toxicities experienced between the start of radiotherapy and 3 months following treatment.
Measured: 3 months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start14 Mar 2024
- Primary completion1 Nov 2028 (estimated)
- Study completion14 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
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, MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080503
- Sponsor's protocol ID
- 2023-0715
- Acronym
- G-FORCE
- Status last verified
- Nov 2025
- First submitted
- 6 Oct 2023
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G-FORCE: Phase II Randomized Study of Glottic Larynx Hypofractionated Radiotherapy Versus ConvEntional Radiotherapy
- ClinicalTrials.gov ID
- NCT06080503
- Acronym / sponsor ID
- G-FORCE / 2023-0715
- Conditions
- Laryngeal Carcinoma
- Keywords
- Larynx
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 14 Mar 2029 (estimated)
- First posted
- 12 Oct 2023 (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.
To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy.
Detailed description
Screening/Baseline Procedures Assessments performed exclusively to determine eligibility for this study will be done only after obtaining informed consent. Assessments performed for clinical indications (not exclusively to determine study eligibility) may be used for baseline values even if the studies were done before informed consent was obtained.
All screening procedures must be performed within 30 days prior to registration into the study unless otherwise stated. The screening procedures include:
Informed Consent Medical history--Complete medical and surgical history Demographics--Age, gender, race, ethnicity Review subject eligibility criteria Review previous and concomitant medications Physical exam including vital signs, height and weight Vital signs (temperature, pulse, respirations, blood pressure), height, weight Performance status--Performance status evaluated prior to study entry. If there is any variability in the physicians' notes, the higher number will be used for research purposes.
Positron emission tomography-computerized tomography or computerized tomography of neck (any time prior to registration) Laryngoscopy Pregnancy test (for females of child-bearing potential) Quality of life Questionnaires and Symptom Questionnaires --EORTC QLQ-C30, H\&N 35, VHI, and EQ-5D. These forms will be referred to collectively as QoL Questionnaires. Can be given on paper, over the phone, or in EPIC as needed.
Procedures During Treatment Day 1-First fraction of radiotherapy per standard, departmental stereotactic protocol
Follow-up Procedures--After initial follow-up at 2 weeks (+/- 7 days) after completion of radiation therapy, subjects will be followed at 3 months and 12 months. These protocol mandated procedures will occur at each follow-up:
Interim history Physical exam, vital signs, ECOG Performance Status Laryngoscopy (optional at 1-2 weeks) to assess tumor response and toxicity Quality of life and voice quality assessment. Can be given on paper, over the phone, or in EPIC as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Highly conformal hypofractionated radiotherapy | Experimental | Radiation: LT-SABRLT-SABR 42.5 Gy in 5 fractions Low-risk: twice/week Moderate-risk: weekly |
| Conventional radiotherapy | Experimental | Radiation: IMRTConventional Radiotherapy 63 Gy in 28 fractions (T1) 65.25 Gy in 29 fractions (T2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 0-II (AJCC, 8th 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.
- Minimum age is 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 (8 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 |
|---|---|---|
| LT-SABR42.5 Gy in 5 fractions Low-risk: twice/week Moderate-risk: weekly | Radiation | Highly conformal hypofractionated radiotherapy |
| IMRT63 Gy in 28 fractions (T1) 65.25 Gy in 29 fractions (T2) | Radiation | Conventional radiotherapy |
Primary outcome
To compare the acute toxicity outcomes between patients treated with highly-conformal hypofractionated radiotherapy and conventional radiotherapy.
Time frame: 3 months following treatment
Acute toxicity score (i.e. T score), defined as the mean number of grade 2 or higher acute toxicities experienced between the start of radiotherapy and 3 months following 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 26 Nov 2025.
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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.
David Sher, MD, MPH 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 LT-SABR and IMRT in people with Laryngeal 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 9 inclusion and 8 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 26 Nov 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?
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 David J Sher, MD,MPH (214-645-2465, David.Sher@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the acute toxicity outcomes between patients treated with highly-conformal hypofractionated radiotherapy and conventional radiotherapy. (time frame: 3 months following 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 26 Nov 2025.