Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04901234

Adaptive RadioTherapy for OroPharynx Cancer

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2023-12-12

120

Participants Needed

2

Research Sites

278 weeks

Total Duration

On this page

Sponsors

C

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

A

Austin Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a phase II randomized trial, where patients with histologically proven squamous cell carcinoma of oropharynx that have primary tumor (T3 - T4) in place, treated with curative intent chemoradiation, will be randomized to systematic mid-treatment MRI-based radiotherapy adaptation vs. standard of care. The primary objective is to compare patient-rated dysphagia (as assessed by the MD Anderson Dysphagia Inventory composite score at 6 months post-treatment in patients undergoing routine mid-treatment MR-guided radiotherapy adaptation vs. in patients receiving the current standard of care.

CONDITIONS

Official Title

Adaptive RadioTherapy for OroPharynx Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �318 years
  • Ability to provide written informed consent
  • Stage T3-T4N0-3 as per AJCC 8th edition
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx
  • Planned for curative radiotherapy with or without chemotherapy
  • For females of child-bearing age, a negative pregnancy test
  • Patients treated with induction chemotherapy can be included if they have residual tumor in place
Not Eligible

You will not qualify if you...

  • Previous irradiation of the head and neck region, excluding superficial radiation therapy for non-melanomatous skin cancer
  • Previous surgery of the head and neck region except for biopsies
  • Pregnancy or breastfeeding
  • Connective tissue disease
  • Any medical condition that could prevent follow-up after radiotherapy
  • Contraindications to MRI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Austin Health

Melbourne, Australia

Not Yet Recruiting

2

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada, H2x 3E4

Actively Recruiting

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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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