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Radiation Therapy

MRI-Guided Radiotherapy for Throat Cancer (ART-OPC Trial)

Phase 2

Recruiting

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Planned for curative radiotherapy +/- chemotherapy

Must not have

Connective tissue disease

Previous surgery of the HNC region (except for incisional or excisional biopsies)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from treatment start to 5-years after the end of chemoradiation]

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using MRI to guide radiotherapy treatment for patients with squamous cell carcinoma of the oropharynx (throat) results in less dysphagia (difficulty swallowing) than the current standard of care.

Who is the study for?

Adults with advanced oropharyngeal cancer (stage T3-T4) who can undergo curative radiotherapy with or without chemotherapy. Participants must be able to consent, have an ECOG performance status of 0-2, and women must not be pregnant. Exclusions include prior head/neck radiation (except for certain skin cancers), previous HNC surgery other than biopsies, pregnancy/breastfeeding, connective tissue disease, conditions preventing follow-up, and MRI contraindications.

What is being tested?

This phase II trial is testing whether adapting radiotherapy based on mid-treatment MRI results improves swallowing difficulties compared to standard care in patients with squamous cell carcinoma of the oropharynx. Patients are randomly assigned to either the experimental MRI-guided adaptation group or the standard treatment group.

What are the potential side effects?

Potential side effects from both standard and experimental treatments may include typical reactions to radiotherapy such as soreness in the treated area, trouble swallowing, dry mouth, fatigue, skin changes at the site of treatment and possible chemotherapy-related issues like nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for radiotherapy aimed at curing my cancer, with or without chemotherapy.

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I am able to get out of my bed or chair and move around.

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My cancer is at a locally advanced stage but may not have spread to distant parts.

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I have been diagnosed with throat cancer through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a connective tissue disease.

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I have had surgery in the head or neck area, excluding minor biopsies.

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I have had radiation therapy on my head or neck, not for skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from treatment start to 5-years after the end of chemoradiation]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from treatment start to 5-years after the end of chemoradiation]

This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment start to 5-years after the end of chemoradiation] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-reported dysphagia

Secondary study objectives

Acute and late toxicities

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adaptive radiotherapyExperimental Treatment1 Intervention

Systematic radiation treatment plan adaptation according to the shrinking tumour on mid-treatment MRI.

Group II: Standard radiotherapyActive Control1 Intervention

Radiotherapy as planned at baseline, with replanning allowed only if significant weight loss or change in anatomy due to unforeseen circumstances (eg that would affect dosimetry and treatment delivery of baseline treatment plan). No adaptation to shrinking tumour is allowed.

0 / 8Eligibility criteria met