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)
Progression free survival — 2 years after the end of chemoradiation Patient alive with no local, regional or distant recurrence at 2 years after the end of chemoradiation
Trial sites (2)
Facility
City
Region
Status
London Health Sciences Center
London
Ontario
Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal
Quebec
Recruiting
More Centre hospitalier de l'Université de Montréal (CHUM) trials in Canada
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.