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
Centre hospitalier de l'Université de Montréal (CHUM)
360 participants
Feb 23, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria9
- 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
Interventions
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 Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04178174