Glottic CarcinomaPhase 2VOICENCT07895745
Volumetric Adaptive SBRT Versus Conventional Accelerated Radiation Therapy for Early-Stage Glottic Cancer
A Phase 2 study testing Long course accelerated fractionation radiation therapy and Adaptive stereotactic body radiation therapy in people with Glottic Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This non-inferiority trial will compare conventional long-course accelerated fractionation radiation therapy (AF-RT) with volumetric adaptive stereotactic body radiation therapy (SBRT) in patients with early-stage (cT1-2N0M0) glottic squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glottic Carcinoma
- What is being tested?
- Long course accelerated fractionation radiation therapy and Adaptive stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2027to 1 Jan 2032
- Phase
- Phase 2
- 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 glottic SCC.
- Patients are planned to receive definitive RT
- Stage cT1-2 N0 M0 (UICC/AJCC TNM 8th Edition).
- Must be ≥ 18 years of age.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. Consent to provision of samples for correlative studies is optional.
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- Women of childbearing potential must use an accepted and effective method of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 3 months after the last day of RT. Sexually active males must use an accepted and effective method of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 3 months after RT.
- Women must not be pregnant or breast-feeding. All females of childbearing potential must have a serum or urine pregnancy test to rule out pregnancy within 4 weeks prior to registration. All breastfeeding women should discontinue breastfeeding prior to study registration.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Who cannot join
- Stage III-IV larynx cancer
- Patients with synchronous primary head and neck cancer outside of the larynx
- Prior chemotherapy for treatment of the targeted larynx lesion
- Prior RT to the head and neck region that would result in significant overlap of RT volume for the current study.
- Patients who are deemed to require concurrent chemotherapy for treatment of the targeted larynx lesion
- Involvement of the arytenoid cartilage beyond the vocal process
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- No macroscopic residual disease following diagnostic biopsy or excision (i.e., no identifiable GTV for target delineation)
- Planning target volume ≥10 cc, defined as the SBRT-arm PTV (Section 6.3.8) contoured on the pre-randomization simulation scan
- Reported smoking within 14 days from registration to the study.
- Individuals with severe, active co-morbidity including any of the following: Chronic obstructive pulmonary disease or other pulmonary illness requiring hospitalization within 30 days of study registration, Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of study registration, Acute myocardial infarction within 30 days of study registration, Diseases precluding RT (e.g., active scleroderma or lupus)
- Participants must not be receiving any other standard anti-cancer therapy or experimental agent concurrently with RT.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Ali Hosni Abdalaty, 416-946-2124, ali.hosni@uhn.ca
About this study
Official title: Volumetric Adaptive SBRT Versus Conventional Accelerated Radiation: Investigating Outcomes In a Phase II Randomized Controlled Trial for Early Stage Glottic Cancer (VOICE)
This non-inferiority trial will compare conventional long-course accelerated fractionation radiation therapy (AF-RT) with volumetric adaptive stereotactic body radiation therapy (SBRT) in patients with early-stage (cT1-2N0M0) glottic squamous cell carcinoma. Participants will be randomized in a 1:2 ratio to receive either AF-RT (Arm A) or adaptive SBRT (Arm B).
The primary objective is to determine whether adaptive SBRT provides non-inferior local control compared with AF-RT in patients with early-stage glottic squamous cell carcinoma. Secondary analyses will evaluate treatment-related toxicity and other clinical outcomes.
The study hypothesizes that adaptive SBRT will achieve local control rates that are non-inferior to those of AF-RT while offering a substantially shorter treatment course. Imaging biomarkers, transcriptome/methylome profiles, plasma biomarkers, and cfDNA will be analyzed to identify novel biomarkers that predict oncologic outcomes and treatment-related toxicity.
- Conditions
- Glottic Carcinoma
- Being tested
- Long course accelerated fractionation radiation therapy, Adaptive stereotactic body radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long course accelerated fractionation radiation therapyRadiation
RT will be administered as 6 fractions per week (single fraction per day with one day of the week has 2 fractions, 6 hours apart), 5 days per week, based on the following prescription:
PTV_6600 (high dose target for cT1 tumor): will receive 66 Gy over 33 fractions in 5.5 weeks
PTV_7000 (high dose target for cT2 tumor): will receive 70 Gy over 35 fractions in 6 weeks
PTV_5600 (elective dose target): will receive 56 Gy over 33-35 fractions in 5.5-6 weeks
Adaptive stereotactic body radiation therapyRadiation
RT will be administered as 2 fractions per week, with at least 2 days between consecutive fractions (e.g., Monday/Thursday), over 2 weeks, as follows:
PTV_4000 (high dose target for cT1 tumor): will receive 40 Gy over 5 fractions in 2 weeks
PTV_4250 (high dose target for cT2 tumor): will receive 42.5 Gy over 5 fractions in 2 weeks
PTV_2500 (elective dose target): will receive 25 Gy over 5 fractions in 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Accelerated fractionation radiation therapy (AF-RT) | Experimental | Not described Receives: Radiation: Long course accelerated fractionation radiation therapy |
| Adaptive stereotactic body radiation therapy (Adaptive SBRT). | Experimental | Not described Receives: Radiation: Adaptive stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control (LC)
Local control (LC), defined as the time from randomization to the date of local failure, after comprehensive clinical examination and radiographic evaluation.
Measured: From randomization until local failure or last follow-up (up to 2 years)
Secondary outcomes (13)
Locoregional Failure (LRF)
Measured: 2 Years
Distant Metastasis (DM)
Measured: 2 Years
Laryngectomy free survival (LFS)
Measured: 2 Years
Disease free survival (DFS)
Measured: 2 Years
Overall survival (OS)
Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause.
Measured: 2 Years
Physician-assessed toxicities
National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.6, where higher grades indicate greater severity of toxicity.
Measured: 2 Years
Patient-reported toxicities
Patient Reported Outcomes - Common Terminology Criteria of Adverse Events (PRO CTCAE) V.1, where higher scores indicate greater symptom burden and worse patient-reported toxicity.
Measured: 2 Years
Quality of life (QOL) (UW-QOL)
Head and Neck Cancer Specific QOL [University of Washington Quality of Life Questionnaire (UW-QOL)], where higher scores indicate a better quality of life.
Measured: 2 years
Quality of life (QOL): Voice Handicap Index (VHI)
Voice Handicap Index (VHI): a patient-reported questionnaire that assesses the functional, physical, and emotional impact of voice disorders, where higher scores indicate greater voice-related handicap.
Measured: 2 Years
Quality of life (QOL): Swallowing-related quality of life [M.D. Anderson Dysphagia Inventory (MDADI)]
Swallowing-related quality of life [M.D. Anderson Dysphagia Inventory (MDADI)]: a patient-reported questionnaire assessing the impact of dysphagia on quality of life. Higher scores indicate better swallowing-related quality of life.
Measured: 2 Years
Financial Toxicity
Financial Index of Toxicity (FIT)]: assesses the financial burden and impact of cancer treatment on patients. Higher scores indicate greater financial toxicity
Measured: 2 Years
Health Economics (EQ-5D-5L)
Cost-utility analysis using health utilization costs and health utility instruments (EQ-5D-5L), including lost productivity. Higher scores indicate better health-related quality of life.
Measured: 2 Years
Health Economics (HNC-8D)
Cost-utility analysis using health utilization costs and health utility instruments (HNC-8D), including lost productivity. Higher scores indicate better health status.
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 posted26 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glottic CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895745
- Sponsor's protocol ID
- 26-5989
- Acronym
- VOICE
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Adaptive SBRT Versus Conventional Accelerated Radiation: Investigating Outcomes In a Phase II Randomized Controlled Trial for Early Stage Glottic Cancer (VOICE)
- ClinicalTrials.gov ID
- NCT07895745
- Acronym / sponsor ID
- VOICE / 26-5989
- Conditions
- Glottic Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 26 Oct 2026 (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.
This non-inferiority trial will compare conventional long-course accelerated fractionation radiation therapy (AF-RT) with volumetric adaptive stereotactic body radiation therapy (SBRT) in patients with early-stage (cT1-2N0M0) glottic squamous cell carcinoma. Participants will be randomized in a 1:2 ratio to receive either AF-RT (Arm A) or adaptive SBRT (Arm B).
The primary objective is to determine whether adaptive SBRT provides non-inferior local control compared with AF-RT in patients with early-stage glottic squamous cell carcinoma. Secondary analyses will evaluate treatment-related toxicity and other clinical outcomes.
The study hypothesizes that adaptive SBRT will achieve local control rates that are non-inferior to those of AF-RT while offering a substantially shorter treatment course. Imaging biomarkers, transcriptome/methylome profiles, plasma biomarkers, and cfDNA will be analyzed to identify novel biomarkers that predict oncologic outcomes and treatment-related toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated fractionation radiation therapy (AF-RT) | Experimental | Radiation: Long course accelerated fractionation radiation therapy |
| Adaptive stereotactic body radiation therapy (Adaptive SBRT). | Experimental | Radiation: Adaptive stereotactic body radiation therapy |
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 glottic SCC.
- Patients are planned to receive definitive RT
- Stage cT1-2 N0 M0 (UICC/AJCC TNM 8th Edition).
- Must be ≥ 18 years of age.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Key exclusion criteria (11 listed)
- Stage III-IV larynx cancer
- Patients with synchronous primary head and neck cancer outside of the larynx
- Prior chemotherapy for treatment of the targeted larynx lesion
- Prior RT to the head and neck region that would result in significant overlap of RT volume for the current study.
- Patients who are deemed to require concurrent chemotherapy for treatment of the targeted larynx lesion
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 |
|---|---|---|
| Long course accelerated fractionation radiation therapyRT will be administered as 6 fractions per week (single fraction per day with one day of the week has 2 fractions, 6 hours apart), 5 days per week, based on the following prescription: PTV_6600 (high dose target for cT1 tumor): will receive 66 Gy over 33 fractions in 5.5 weeks PTV_7000 (high dose target for cT2 tumor): will receive 70 Gy over 35 fractions in 6 weeks PTV_5600 (elective dose target): will receive 56 Gy over 33-35 fractions in 5.5-6 weeks | Radiation | Accelerated fractionation radiation therapy (AF-RT) |
| Adaptive stereotactic body radiation therapyRT will be administered as 2 fractions per week, with at least 2 days between consecutive fractions (e.g., Monday/Thursday), over 2 weeks, as follows: PTV_4000 (high dose target for cT1 tumor): will receive 40 Gy over 5 fractions in 2 weeks PTV_4250 (high dose target for cT2 tumor): will receive 42.5 Gy over 5 fractions in 2 weeks PTV_2500 (elective dose target): will receive 25 Gy over 5 fractions in 2 weeks | Radiation | Adaptive stereotactic body radiation therapy (Adaptive SBRT). |
Primary outcome
Local Control (LC)
Time frame: From randomization until local failure or last follow-up (up to 2 years)
Local control (LC), defined as the time from randomization to the date of local failure, after comprehensive clinical examination and radiographic evaluation.
13 secondary outcomes
Locoregional Failure (LRF)
Time frame: 2 Years
Distant Metastasis (DM)
Time frame: 2 Years
Laryngectomy free survival (LFS)
Time frame: 2 Years
Disease free survival (DFS)
Time frame: 2 Years
Overall survival (OS)
Time frame: 2 Years
Physician-assessed toxicities
Time frame: 2 Years
Patient-reported toxicities
Time frame: 2 Years
Quality of life (QOL) (UW-QOL)
Time frame: 2 years
Quality of life (QOL): Voice Handicap Index (VHI)
Time frame: 2 Years
Quality of life (QOL): Swallowing-related quality of life [M.D. Anderson Dysphagia Inventory (MDADI)]
Time frame: 2 Years
Financial Toxicity
Time frame: 2 Years
Health Economics (EQ-5D-5L)
Time frame: 2 Years
Health Economics (HNC-8D)
Time frame: 2 Years
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 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Long course accelerated fractionation radiation therapy and Adaptive stereotactic body radiation therapy in people with Glottic Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
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 11 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control (LC) (time frame: From randomization until local failure or last follow-up (up to 2 years)). 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 Oct 2026.