MRI-Guided Radiotherapy for Throat Cancer

(ART-OPC Trial)

Recruiting at1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Disqualifiers: Previous head and neck irradiation, Pregnancy, Connective tissue disease, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment MRI-Guided Radiotherapy for Throat Cancer?

Research shows that MRI-guided radiotherapy (MRgRT) offers better soft tissue contrast than traditional methods, which helps in accurately targeting the cancer while sparing healthy tissues. This approach is particularly beneficial for head and neck cancers, as it allows for precise treatment adjustments based on daily imaging, potentially reducing side effects and improving outcomes. ^{1 2 3 4 5}

Is MRI-guided radiotherapy for throat cancer safe for humans?

MRI-guided radiotherapy for head and neck cancer, including throat cancer, is being studied for its safety and feasibility. While traditional methods can cause significant side effects, this new approach aims to reduce those by adapting to changes in the tumor and surrounding tissues during treatment. ^{1 2 4 6 7}

How is MRI-guided radiotherapy different from other treatments for throat cancer?

MRI-guided radiotherapy for throat cancer is unique because it uses detailed MRI images to precisely target the cancer, allowing for better adaptation to changes in the tumor and surrounding tissues during treatment. This approach can reduce side effects and improve treatment effectiveness compared to traditional methods. ^{1 8 9 10 11}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

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

I am of child-bearing age and my pregnancy test is negative.

Exclusion Criteria

Pregnancy or breastfeeding

I have a connective tissue disease.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemoradiation with either standard radiotherapy or adaptive radiotherapy based on mid-treatment MRI

7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including patient-reported dysphagia and toxicities

5 years

Visits at 1, 3, 12 months post-treatment, and yearly up to 5 years

Treatment Details

Interventions

• Experimental radiotherapy (Radiation Therapy)
• Standard radiotherapy (Radiation Therapy)

Trial Overview 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.

Participant Groups

Group I: Adaptive radiotherapy Experimental Treatment 1 Intervention

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

Group II: Standard radiotherapy Active Control 1 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.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Dr. Réjean Lapointe

Centre hospitalier de l'Université de Montréal (CHUM)

Chief Medical Officer since 2023

MD from Université de Montréal

Dr. Fabrice Brunet

Centre hospitalier de l'Université de Montréal (CHUM)

Chief Executive Officer since 2015

MD from Université de Montréal

Austin Health

Collaborator

Trials

64

Recruited

31,000+

Jodie Geissler

Austin Health

Chief Executive Officer

Master of Public Health (MPH) and Fellowship in Medical Administration (FRACMA)

Professor Mary O'Reilly

Austin Health

Chief Medical Officer since 2022

Master of Public Health (MPH) and Fellowship in Medical Administration (FRACMA)

Findings from Research

Magnetic resonance-guided radiation therapy (MRgRT) is emerging as a promising approach for treating head and neck cancer, utilizing advanced MRI techniques to improve treatment planning and reduce toxicities associated with traditional radiation therapy.

MRgRT offers several advantages, including better anatomical and functional evaluations, the ability to adapt treatments based on daily imaging, and the potential for more effective hypofractionation, which could enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-Guided Radiation Therapy for Head and Neck Cancers. Lavigne, D., Ng, SP., O'Sullivan, B., et al.[2023]

This study demonstrates that daily adaptive radiation therapy (ART) using a 1.5T MR-linac for head and neck cancer is safe and feasible, with a high median gamma pass rate of 99.9%, indicating effective treatment delivery.

The dosimetric results show that the delivered doses were consistent with planned doses, with only minor variations, suggesting that the ART approach can effectively manage treatment while minimizing risks to surrounding organs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Feasibility and Clinical Implementation of Daily MR-Guided Adaptive Head and Neck Cancer Radiation Therapy on a 1.5T MR-Linac System: Prospective R-IDEAL 2a/2b Systematic Clinical Evaluation of Technical Innovation. McDonald, BA., Vedam, S., Yang, J., et al.[2021]

In a study involving 10 patients with pharyngo-laryngeal squamous cell carcinoma, adaptive image-guided intensity-modulated radiotherapy (IMRT) using FDG-PET imaging significantly reduced the target volumes (GTVs) by 15-40% compared to pre-treatment CT planning, indicating improved dose distribution.

The use of FDG-PET for target volume delineation resulted in smaller GTVs compared to traditional CT and MRI methods, which could enhance treatment efficacy while maintaining safety for surrounding organs at risk, such as the spinal cord and parotid glands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive biological image-guided IMRT with anatomic and functional imaging in pharyngo-laryngeal tumors: impact on target volume delineation and dose distribution using helical tomotherapy. Geets, X., Tomsej, M., Lee, JA., et al.[2022]

Adaptive radiotherapy (ART) offers a promising solution to the limitations of traditional intensity-modulated radiotherapy (IMRT) for head and neck cancers by allowing for adjustments based on changes in tumor and surrounding anatomy during treatment.

Early clinical testing of an automated ART platform has shown potential, but technical challenges still need to be addressed before ART can be widely implemented in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current progress in adaptive radiation therapy for head and neck cancer. Schwartz, DL.[2022]

MRI-guided radiotherapy (MRgRT) offers superior soft tissue imaging compared to CT, allowing for more precise targeting of tumors and better protection of nearby sensitive organs during treatment for head and neck squamous cell carcinoma (HNSCC).

The integration of adaptive workflows in MRgRT enables real-time adjustments to treatment plans based on changes in tumor size and position, which is crucial for optimizing radiation delivery and minimizing damage to surrounding healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Target Definition in MR-Guided Adaptive Radiotherapy for Head and Neck Cancer. Ridder, M., Raaijmakers, CPJ., Pameijer, FA., et al.[2022]

Current head and neck intensity-modulated radiotherapy (IMRT) can cause significant toxicity due to its inability to adapt to daily changes in tumor and normal tissue locations, which may lead to unintended exposure of healthy tissues to high radiation doses.

Adaptive radiotherapy (ART) offers a promising solution by allowing for modifications to treatment plans based on daily anatomical changes, and initial clinical findings suggest it could improve treatment safety and efficacy, although technical challenges remain for its routine implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive radiation therapy for head and neck cancer-can an old goal evolve into a new standard? Schwartz, DL., Dong, L.[2021]

Image-guided radiotherapy using MRI enhances the precision of treatment for various cancers, including brain tumors and gastrointestinal diseases, without increasing radiation exposure to patients.

The integration of MRI technology allows for better soft tissue contrast, facilitating adaptive radiotherapy strategies that can improve treatment outcomes and patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adaptative radiotherapy: The case for MRI-guided radiotherapy]. Maingon, P.[2017]

MRI-guided radiotherapy enables real-time adjustments to radiation plans based on changes in patient anatomy and function during treatment, enhancing treatment precision.

This innovative approach has the potential to improve outcomes for patients with various urological cancers by expanding the therapeutic window, allowing for more effective and safer treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Urological Cancers: What Urologists Should Know. Kerkmeijer, LGW., Kishan, AU., Tree, AC.[2022]

In a study of 18 patients with head and neck cancers, MRI-guided radiotherapy resulted in a high complete response rate of 83% and excellent 1-year survival rates (96% overall survival).

The treatment was safe, with no fatalities reported, although 44% of patients experienced significant acute toxicity; nonetheless, many reported improved quality of life post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided radiotherapy for head and neck cancer: initial clinical experience. Chen, AM., Hsu, S., Lamb, J., et al.[2022]

MRI-guided radiation therapy for reirradiation of recurrent head and neck cancers showed a 1- and 2-year in-field control rate of 72%, indicating effective disease management in this challenging patient population.

The treatment was associated with relatively low morbidity, with no treatment-related fatalities or hospitalizations, suggesting that MRI guidance may enhance safety and precision in radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging guided reirradiation of recurrent and second primary head and neck cancer. Chen, AM., Cao, M., Hsu, S., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-Guided Radiation Therapy for Head and Neck Cancers. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Initial Feasibility and Clinical Implementation of Daily MR-Guided Adaptive Head and Neck Cancer Radiation Therapy on a 1.5T MR-Linac System: Prospective R-IDEAL 2a/2b Systematic Clinical Evaluation of Technical Innovation. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Adaptive biological image-guided IMRT with anatomic and functional imaging in pharyngo-laryngeal tumors: impact on target volume delineation and dose distribution using helical tomotherapy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Current progress in adaptive radiation therapy for head and neck cancer. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Target Definition in MR-Guided Adaptive Radiotherapy for Head and Neck Cancer. [2022]

6. Egypt pubmed.ncbi.nlm.nih.gov

Adaptive radiation therapy for head and neck cancer-can an old goal evolve into a new standard? [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A daily end-to-end quality assurance workflow for MR-guided online adaptive radiation therapy on MR-Linac. [2020]

8. France pubmed.ncbi.nlm.nih.gov

[Adaptative radiotherapy: The case for MRI-guided radiotherapy]. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Urological Cancers: What Urologists Should Know. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

MRI-guided radiotherapy for head and neck cancer: initial clinical experience. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging guided reirradiation of recurrent and second primary head and neck cancer. [2020]