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Not yet recruitingNCT07895745VOICEUpdated Oct 26, 2026

Volumetric Adaptive SBRT Versus Conventional Accelerated Radiation Therapy for Early-Stage Glottic Cancer

A Phase 2 interventional study of Long course accelerated fractionation radiation therapy and Adaptive stereotactic body radiation therapy in Glottic Carcinoma, sponsored by University Health Network, Toronto. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Glottic Carcinoma
03

In context

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,434 studies on the registry; 293 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Browse University Health Network, Toronto studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Accelerated fractionation radiation therapy (AF-RT)

    Radiation: Long course accelerated fractionation radiation therapy

  • Experimental
    Adaptive stereotactic body radiation therapy (Adaptive SBRT).

    Radiation: Adaptive stereotactic body radiation therapy

Interventions

  • RadiationLong course accelerated fractionation radiation therapy

    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

  • RadiationAdaptive stereotactic body radiation therapy

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From randomization until local failure or last follow-up (up to 2 years)

Secondary outcomes

  1. Locoregional Failure (LRF)

    Time frame: 2 Years

  2. Distant Metastasis (DM)

    Time frame: 2 Years

  3. Laryngectomy free survival (LFS)

    Time frame: 2 Years

  4. Disease free survival (DFS)

    Time frame: 2 Years

  5. 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.

    Time frame: 2 Years

  6. Physician-assessed toxicities

    National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.6, where higher grades indicate greater severity of toxicity.

    Time frame: 2 Years

  7. 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.

    Time frame: 2 Years

  8. 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.

    Time frame: 2 years

  9. 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.

    Time frame: 2 Years

  10. 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.

    Time frame: 2 Years

  11. Financial Toxicity

    Financial Index of Toxicity (FIT)\]: assesses the financial burden and impact of cancer treatment on patients. Higher scores indicate greater financial toxicity

    Time frame: 2 Years

  12. 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.

    Time frame: 2 Years

  13. 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.

    Time frame: 2 Years

07

Study locations

1 site
  • Princess Margaret Cancer Center
    Toronto, Ontario M5G 2M9, Canada
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07895745
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Jan 1, 2032 (estimated)
Completion
Jan 1, 2032 (estimated)
Last update
Oct 26, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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