Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04178174

Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-05-18

360

Participants Needed

2

Research Sites

509 weeks

Total Duration

On this page

Sponsors

C

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

M

M.D. Anderson Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 218 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 or HPV in-situ hybridization
  • Clinical stage T1-3, N1 M0 (Stage I-II) as per AJCC 8th edition
  • Primary tumor smaller than 30 cc
  • Planned for curative chemoradiation
  • For females of child-bearing age, a negative pregnancy test
Not Eligible

You will not qualify if you...

  • Clinical N3 classification as per AJCC 8th edition
  • Clinically overt extranodal extension (ENE) defined by invasion of skin, musculature, fixation to adjacent structures, or nerve invasion with dysfunction
  • Previous irradiation of the head and neck region
  • Previous surgery of the head and neck region except biopsies
  • Pregnancy or breastfeeding
  • Connective tissue disease
  • Any medical condition preventing follow-up after radiotherapy
  • Use of non-Cisplatin concurrent chemotherapy
  • Prior induction chemotherapy

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

London Health Sciences Center

London, Ontario, Canada

Actively Recruiting

2

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada, H2X 1R6

Actively Recruiting

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Research Team

D

Diane Trudel

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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