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Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer

Head and Neck Cancer | Human Papilloma Virus | Oropharynx Cancer

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.

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    18 and up

Critères de participation

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

Lieu de l'étude

Centre Hospitalier de l'Université de Montréal
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
Canada

Contactez l'équipe d'étude

London Health Sciences Center
London Health Sciences Center
London, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Karen Eddy

[email protected]
(519) 685-8500
Étude parrainée par
Centre hospitalier de l'Université de Montréal (CHUM)
Participants recherchés
Plus d'informations
ID de l'étude: NCT04178174