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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

ART-OPC Trial 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.Check my eligibility

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.See study design

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.

ART-OPC Trial 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.

ART-OPC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Acute and late toxicities

Other outcome measures

Complete response rate

Disease-free survival

Locoregional control

+2 more

ART-OPC 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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,517 Total Patients Enrolled

Austin HealthOTHER_GOV

62 Previous Clinical Trials

30,869 Total Patients Enrolled

Media Library

Experimental radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04901234 — Phase 2

Oropharyngeal Cancer Research Study Groups: Standard radiotherapy, Adaptive radiotherapy

Oropharyngeal Cancer Clinical Trial 2023: Experimental radiotherapy Highlights & Side Effects. Trial Name: NCT04901234 — Phase 2

Experimental radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04901234 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment available for this clinical research endeavor?

"Affirmative. Reports on clinicaltrials.gov verify that this experiment commenced its search for participants in July 2021 and is ongoing as of November 2022. The study aims to recruit 120 individuals from a single medical site."

Answered by AI

How many individuals are currently engaging in this research endeavor?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial is currently recruiting participants; it was first posted on July 30th 2021 and the most recent update was made on November 11th 2022. This study seeks 120 individuals at a single site of recruitment."

Answered by AI

Are there any potential risks associated with Experimental radiotherapy +/- chemotherapy?

"This experimental radiotherapy +/ chemotherapy has an assigned safety score of 2 due to the lack of evidence demonstrating efficacy, although there is a degree of data that supports its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adaptive RadioTherapy for OroPharynx Cancer

Houda Bahig 2021. "Adaptive RadioTherapy for OroPharynx Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04901234.

All > Dysphagia