A Phase 3 interventional study of SABR boost and de-escalated chemoradiation and Standard chemoradiation in Head and Neck Cancer, Oropharynx Cancer and Human Papilloma Virus, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Phase 3, Interventional, and Treatment
This is a randomized clinical trial comparing the outcomes of short-course chemoradiation consisting in stereotactic boost to the gross tumor and de-esclalated chemoradiation to the elective neck in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation.
Concurrent platinum-based chemoradiation remains the standard of care in locally advanced head and neck cancer. The current standard radiation regimen consists in a 7-week course of conventionally fractionated radiotherapy to the gross tumor volume (GTV), along with bilateral prophylactic neck irradiation to an elective dose of \~ 50 Gy in 2 Gy per fraction. In addition to being cumbersome, the current protracted daily radiation course is associated with high rates of acute and late toxicities and significant deterioration of patients' quality of life. In the light of the remarkably improved prognosis of the distinct subgroup of HPV-OPC, there is growing interest for treatment de-intensification strategies in contemporaneous OPC cohorts.
Stereotactic ablative radiotherapy (SABR) allows for ultra-precise delivery of ablative radiation dose over a small number of fractions, by combining sharp dose gradients with use of optimal image guidance. The increased conformity and reduced margins used in SABR can substantially reduce the dose to surrounding organs at risk and could therefore reduce toxicity. In addition, previous work has shown that an elective dose of 40 Gy in 2 Gy per fraction, in conjunction with chemotherapy, is sufficient for microscopic sterilisation of cancer cells and can translate into a reduction of toxicities.
The goal of this trial is to compare the efficacy and safety of short-course chemoradiation consisting in stereotactic boost to the gross tumor of 14 Gy in 2 fractions followed by de-esclalated chemoradiation (40 Gy in 20 fractions and concurrent 2 cycles of Cisplatin 100mg/m2) in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation (70 Gy in 33 fractions with 2-3 cycles of Cisplatin 100mg/m2).
This is an open label randomized phase III non inferiority trial. Patients will be randomized using a 1:1 ratio between the standard and the experimental arm and will be stratified by tumor stage and use of concurrent chemotherapy.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's planned enrollment of 360 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
SABR boost of 14 Gy in 2 fractions to the GTV, immediately followed by de-escalated chemoradiation. De-escalated chemoradiation will consist in 40 Gy in 20 fractions with concurrent high dose Cisplatin (3-weekly, 100 mg/m2) for 2 cycles, aiming for a cumulative dose of 200 mg/m2.
Radiation: SABR boost and de-escalated chemoradiation
The standard arm will consist of conventionally radiation to a dose of 70 Gy in 33 fractions concurrently with high dose Cisplatin (3-weekly, 100 mg/m2) for 2-3 cycles, aiming for a cumulative dose of ≥ 200 mg/m2.
Radiation: Standard chemoradiation
Stereotactic body radiotherapy boost to the gross tumor volume to a dose of 14 Gy in 2 fractions, followed by cisplatin-based chemoradiation to a dose of 40 Gy in 20 fractions
Standard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions
Progression free survival
Patient alive with no local, regional or distant recurrence at 2 years after the end of chemoradiation
Time frame: 2 years after the end of chemoradiation
Subacute toxicity
Rate of grade ≥ 3 subacute toxicity
Time frame: Between 2 and 6 months after the end of chemoradiation
Acute toxicity
Rate of grade ≥ 3 acute toxicity
Time frame: Less than 2 months after the end of chemoradiation
Late toxicity
Rate of grade ≥ 3 late toxicity
Time frame: Between 6 months and 5-years after the end of chemoradiation
OS
Overall survival
Time frame: At 2- and 5-years after the end of chemoradiation
locoregional control
Patient alive with locoregional control
Time frame: At 2- and 5-years after the end of chemoradiation
Head and neck symptom burden
Patient-reported head and neck symptom burden as measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module. The core and head and neck cancer specific symptoms are rated on a 0-10 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.
Time frame: At baseline, and 1-, 3-, 6-, 12- months post-treatment, and yearly from years 2-5 after the end of chemoradiation
Dysphagia
Patient-reported dysphagia as measured by the MD Anderson Dysphagia Index. Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.
Time frame: At baseline, and 1-, 3-, 6-, 12- months post-treatment, and yearly from years 2-5 after the end of chemoradiation
Time from treatment start to return to work
Time from first day of treatment start to first day of return to work.
Time frame: Measured in days and reported at 2-years post-treatment
Plan to share: No
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Centre hospitalier de l'Université de Montréal (CHUM)