MRI-Guided Radiotherapy for Throat Cancer

(ART-OPC Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 7 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adapting radiotherapy using MRI scans during treatment can reduce swallowing difficulties for people with advanced throat cancer. It compares two approaches: the experimental group receives radiotherapy adjusted for tumor changes (experimental radiotherapy), while the other group receives standard treatment without adjustment (standard radiotherapy). The main aim is to determine which method better preserves the ability to swallow six months after treatment. People with advanced squamous cell carcinoma of the throat who plan to receive radiotherapy and have not had prior head or neck radiation may be suitable for this trial. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering a chance to contribute to important advancements in cancer 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 prior data suggests that this MRI-guided radiotherapy is safe for treating throat cancer?

Studies have shown that adaptive radiotherapy, which adjusts the treatment plan based on changes in tumor size during therapy, is generally safe for patients with head and neck cancer. Research indicates that this method carries a low risk of severe side effects. For instance, one study found that only 8% of patients experienced moderate or worse skin reactions from the radiation. This suggests that most patients tolerate adaptive radiotherapy well.

For those considering joining a trial, past research has demonstrated promising safety results for this type of treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about MRI-guided radiotherapy for throat cancer because it offers a new level of precision and adaptability. Unlike standard radiotherapy, which sticks to an initial treatment plan, adaptive radiotherapy adjusts the radiation plan mid-treatment based on real-time MRI scans of the shrinking tumor. This could lead to more effective targeting of cancer cells while sparing healthy tissue, potentially reducing side effects and improving outcomes. By tailoring treatment to the tumor's current size and shape, this approach aims to optimize the therapeutic impact of radiotherapy.

What evidence suggests that this trial's radiotherapy treatments could be effective for throat cancer?

Research has shown that adaptive radiotherapy, one of the treatments studied in this trial, can better target tumors while minimizing damage to healthy tissues in patients with head and neck cancer. Some studies have found that this approach can reduce the extra area needed around the tumor, potentially protecting healthy parts of the body. Although one study did not find major improvements in patient well-being, adaptive radiotherapy has proven practical and generally well-tolerated. Early results suggest it might improve saliva production compared to standard treatments, which is the other treatment arm in this trial. Overall, adaptive radiotherapy offers a promising way to enhance patient comfort and treat cancer more precisely. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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

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

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

Exclusion Criteria

Pregnancy or breastfeeding

I have a connective tissue disease.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Experimental radiotherapy
• Standard radiotherapy

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.

How Is the Trial Designed?

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+

Austin Health

Collaborator

Trials

64

Recruited

31,000+

Published Research Related to This Trial

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]

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 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]

The newly developed end-to-end quality assurance (QA) workflow for MR-guided online adaptive radiation therapy (MRgOART) takes only 10 minutes to complete and effectively checks the performance and connectivity of all components involved, ensuring safe and accurate treatment delivery.

This QA process has successfully identified communication issues and discrepancies in isocenter shifts, allowing for timely resolutions before patient treatment, thus enhancing the reliability of MRgOART in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A daily end-to-end quality assurance workflow for MR-guided online adaptive radiation therapy on MR-Linac. Chen, X., Ahunbay, E., Paulson, ES., et al.[2020]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11995038/

Adaptive radiotherapy for oropharyngeal cancer with daily ... Treatment with a daily ATS workflow for OPSCC was feasible and well tolerated. MRgRT use might be a mean to reduce CTV-PTV margins.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405631625000016

Adaptive radiotherapy in locally advanced head and neck ... In the ARTIX trial, a phase 3 randomized trial of 132 oropharyngeal cancer patients, ART did not significantly improve patient-reported outcomes, or rates of ...

3. redjournal.org redjournal.org/article/S0360-3016(25)04026-X/abstract

Adaptive Radiotherapy Using PRECISE ART in Head and ... Adaptive radiotherapy (ART) optimizes tumor coverage while minimizing normal tissue toxicity in head and neck cancer patients. This study evaluates whether ...

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2805682

Weekly Adaptive Radiotherapy vs Standard Intensity ... Objective To assess whether adaptive radiotherapy (ART) improves salivary function compared with IMRT in patients with head and neck cancer.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4271827/

Adaptive Radiotherapy for Head and Neck Cancer To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405630825000400

Adaptive radiotherapy for oropharyngeal cancer with daily ... Data of 34 consecutive patients treated from September 2022 to May 2024 at a single Institution with RCHT on Unity® MR-linac for OPSCC with daily adaptive ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8560706/

Patient-Reported Outcomes-Guided Adaptive Radiation ... Dysphagia-focused ART may provide the greatest toxicity benefit to head and neck cancer patients, and represent a potential new direction for ART.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818117

Safety and Tolerability of Online Adaptive High-Field ... The findings of this study suggest that online adaptive MR-guided radiotherapy is associated with a low risk of high-grade acute toxic effects.

9. redjournal.org redjournal.org/article/S0360-3016(24)03474-6/abstract

Quality and Safety Considerations for Adaptive Radiation ... Adaptive radiation therapy (ART) is the latest topic in a series of white papers published by the American Society for Radiation Oncology ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12434711/

The Paradigm Shift to Real-Time Adaptive Radiotherapy - PMC The initial findings of a randomized phase 2 trial of online ART for head and neck cancer showed lower rates of G2 or higher radiation-induced dermatitis (8% vs ...