Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer
NCT04178174 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360
Last updated 2025-05-18
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.
Conditions
- Head and Neck Cancer
- Oropharynx Cancer
- Human Papilloma Virus
Interventions
- RADIATION
-
SABR boost and de-escalated chemoradiation
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
- RADIATION
-
Standard chemoradiation
Standard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
collaborator OTHER -
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
collaborator OTHER -
Jewish General Hospital
collaborator OTHER -
Centre hospitalier de l'Université de Montréal (CHUM)
lead OTHER
Principal Investigators
-
Houda Bahig, MD PhD · Centre hospitalier de l'Université de Montréal (CHUM)
-
Phuc-Felix Nguyen-Tan, MD · Centre hospitalier de l'Université de Montréal (CHUM)
-
David Palma, MD PhD · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
-
Jack Phan, MD PhD · M.D. Anderson Cancer Center
-
Khalil Sultanem, MD · Montreal Jewish General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-02-23
- Primary Completion
- 2027-12-31
- Completion
- 2029-12-31
Countries
- Canada
Study Locations
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