Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer

Recruiting now · Phase 3

Conditions studied: Head and Neck Cancer, Oropharynx Cancer, Human Papilloma Virus

In brief

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.

Key facts

Study ID

NCT04178174

Run by

Centre hospitalier de l'Université de Montréal (CHUM)

People needed

360

Starts

2020-02-23

Expected to finish

2029-12-01

Last updated by the study team

2025-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• London Health Sciences Center — London, Ontario, Canada (enrolling)
• Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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