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Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID04901234

Adaptive RadioTherapy for Locally Advanced OroPharynx Cancer ART-OPC A Phase II Randomized Trial

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

120

Participants Needed

2

Research Sites

104 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

Researchers are evaluating a new approach to treating patients with squamous cell carcinoma of the oropharynx who have larger primary tumors stage T3-T4. This phase II randomized trial compares the current standard chemoradiation treatment with a new method that adapts radiotherapy based on MRI scans taken mid-treatment. The goal is to see if adjusting radiation therapy according to tumor shrinkage seen on MRI can reduce swallowing difficulties measured six months after treatment. Participants will be randomly assigned to one of two groups. The standard care group receives radiotherapy planned at the start of treatment, with adjustments only if major anatomical changes occur. The experimental group receives systematic radiation plan changes guided by mid-treatment MRI scans to target the shrinking tumor. Both groups may also receive chemotherapy as part of their treatment. This study uses advanced MR-Linac technology to enable detailed imaging during therapy. During the study, patients will undergo assessments including patient-reported swallowing function measured six months after treatment using the MD Anderson Dysphagia Inventory. Researchers will also monitor acute and late side effects for up to five years after chemoradiation. The trial includes safety monitoring and statistical review of interim data to ensure appropriate sample size. Participation involves regular clinical visits, imaging, and questionnaires to track treatment effects and quality of life.

CONDITIONS

Brief Title

Adaptive RadioTherapy for OroPharynx Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Ability to provide written informed consent
  • Stage T3-T4N0-3 squamous cell carcinoma of the oropharynx
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Planned for curative radiotherapy with or without chemotherapy
  • For females of child-bearing age, a negative pregnancy test
  • Patients who had induction chemotherapy can participate if residual tumor remains
Not Eligible

You will not qualify if you...

  • Previous radiation treatment to the head and neck region (except superficial skin radiation for non-melanoma skin cancer)
  • Previous surgery in the head and neck area except biopsies
  • Pregnancy or breastfeeding
  • Connective tissue disease
  • Any medical condition preventing follow-up after radiotherapy
  • Contraindications to MRI scanning

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