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NCT07895745

PHASE2

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

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

Official title: Volumetric Adaptive SBRT Versus Conventional Accelerated Radiation: Investigating Outcomes In a Phase II Randomized Controlled Trial for Early Stage Glottic Cancer (VOICE)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2027-01-01

Completion Date

2032-01-01

Last Updated

2026-10-26

Healthy Volunteers

Conditions

Glottic Carcinoma

Interventions

RADIATION

Long 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

RADIATION

Adaptive 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

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: * 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.

Locations (1)

Princess Margaret Cancer Center

Toronto, Ontario, Canada