Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
SABR boost and de-escalated chemoradiation
RadiationStereotactic 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
RadiationStandard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: SABR boost and de-escalated chemoradiationExperimental treatment 1 intervention
Group B: Standard chemoradiationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Progression free survival
Patient alive with no local, regional or distant recurrence at 2 years after the end of chemoradiation
Time frame
2 years after the end of chemoradiationSecondary outcomes
1
Subacute toxicity
Rate of grade ≥ 3 subacute toxicity
Time frame
Between 2 and 6 months after the end of chemoradiation2
Acute toxicity
Rate of grade ≥ 3 acute toxicity
Time frame
Less than 2 months after the end of chemoradiation3
Late toxicity
Rate of grade ≥ 3 late toxicity
Time frame
Between 6 months and 5-years after the end of chemoradiation4
OS
Overall survival
Time frame
At 2- and 5-years after the end of chemoradiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
M.D. Anderson Cancer Center
Collaborator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborator
Jewish General Hospital
Collaborator
Source ClinicalTrials.gov