NCT04178174RecruitingPhase 3
Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer
Stereotactic Boost and SHOrt-course Radiation Therapy for HPV-associated OroPharynx Cancer Trial: A Randomized Multicentric Phase III Trial
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 17 Nov 2019
- Start date
- 23 Feb 2020
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Diseases
- Head and neck cancer
- NCT number
- NCT04178174
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 360
- From 23 Feb 2020 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous irradiation of the head and neck region
- Previous surgery of the HNC region (except for incisional or excisional biopsies)
- Non-Cisplatin concurrent chemotherapy
- Prior induction chemotherapy
Other illness
- Connective tissue disease
- Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.
Other
- 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).
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Center Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.