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Clinical Trials in Canada / NCT04178174
Recruiting Phase 3

Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer

NCT04178174 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2020-02-23
Last updated
2026-08-24

Condition(s) studied

Head and Neck CancerOropharynx CancerHuman Papilloma Virus

Investigational drug(s) / intervention(s)

SABR boost and de-escalated chemoradiationStandard chemoradiation

SABR boost and de-escalated 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 chemoradiation: Standard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years * Ability to provide written informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx. * Positive for HPV by p16 immunohistochemistry (IHC) or HPV in-situ hybridization (ISH) * Clinical stage T1-3, N1 M0 (Stage I-II) as per AJCC 8th edition. * Primary tumor \< 30 cc * Planned for curative chemoradiation * For females of child-bearing age, a negative pregnancy test Exclusion Criteria: * Clinical N3 classification, as per AJCC 8th edition * Clinically overt extranodal extension (ENE). As per AJCC 8th edition, clinically overt ENE is defined as invasion of the skin, infiltration of musculature/fixation to adjacent structures on clinical examination, cranial nerve, brachial plexus, sympathetic trunk or phrenic nerve invasion with dysfunction). * Previous irradiation of the head and neck region * Previous surgery of the HNC region (except for incisional or excisional biopsies) * Pregnancy or breastfeeding * Connective tissue disease * Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy. * Non-Cisplatin concurrent chemotherapy * Prior induction chemotherapy

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
London Health Sciences Center London Ontario Recruiting
Centre Hospitalier de l'Université de Montréal Montreal Quebec Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04178174 on ClinicalTrials.gov ↗ ← All trials in Canada