MRI-Guided Radiotherapy for Throat Cancer (ART-OPC Trial)
Palo Alto (17 mi)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)
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.
What data supports the idea that MRI-Guided Radiotherapy for Throat Cancer is an effective treatment?The available research shows that MRI-Guided Radiotherapy for Throat Cancer is effective because it provides better imaging of soft tissues, which helps doctors target the cancer more accurately. This means that healthy tissues nearby receive less radiation, potentially reducing side effects. Studies also suggest that this method allows for daily adjustments to the treatment plan, which can improve the accuracy of radiation delivery as the tumor changes. Compared to traditional methods, MRI-Guided Radiotherapy offers improved precision and adaptability, making it a promising option for treating throat cancer.1381011
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is MRI-guided radiotherapy a promising treatment for throat cancer?Yes, MRI-guided radiotherapy is a promising treatment for throat cancer. It uses advanced imaging to better target the cancer, potentially reducing side effects and improving treatment effectiveness. This approach allows doctors to adapt the treatment to changes in the patient's anatomy, making it more precise and personalized.456911
What safety data is available for MRI-guided radiotherapy for throat cancer?The safety data for MRI-guided radiotherapy, also known as adaptive radiotherapy (ART) or MR-guided radiotherapy adaptation, is still emerging. Initial feasibility studies, such as the one using a 1.5T MR-Linac system, focus on safety and feasibility, indicating that this approach is promising but still under investigation. Current literature reviews highlight the potential of MR-guided radiotherapy to reduce toxicity compared to traditional methods like IMRT, by adapting to anatomical changes during treatment. However, technical challenges have limited its routine clinical use, and ongoing research is addressing these issues to improve safety and efficacy.237811
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 able to get out of my bed or chair and move around.
My cancer is at a locally advanced stage but may not have spread to distant parts.
I have been diagnosed with throat cancer through a biopsy.
Exclusion Criteria
I have a connective tissue disease.
I have had surgery in the head or neck area, excluding minor biopsies.
I have had radiation therapy on my head or neck, not for skin cancer.
Treatment Details
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.
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Centre Hospitalier de l'Université de MontréalMontréal, Canada
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
Austin HealthCollaborator
References
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]Adaptive image-guided IMRT appears to be a promising approach for dose escalation in pharyngo-laryngeal tumors. In this framework, we assessed in a proof of concept study the impact of anatomic and functional imaging modalities acquired prior and during radiotherapy on the target volume delineation and the dose distribution using helical tomotherapy.
Adaptive radiation therapy for head and neck cancer-can an old goal evolve into a new standard? [2021]Current head and neck intensity-modulated radiotherapy (IMRT) techniques cause significant toxicity. This may be explained in part by the fact that IMRT cannot compensate for changes in the location of disease and normal anatomy during treatment, leading to exposure of at-risk bystander tissues to higher-than-anticipated doses. Adaptive radiotherapy (ART) is a novel approach to correct for daily tumor and normal tissue variations through online or offline modification of original IMRT target volumes and plans. ART has been discussed on a conceptual level for many years, but technical limitations have hampered its integration into routine care. In this paper, we review the key anatomic, dosimetric, and treatment delivery issues at play in current investigational development of head and neck ART. We also describe pilot findings from initial clinical deployment of head and neck ART, as well as emerging pathways of future research.
Current progress in adaptive radiation therapy for head and neck cancer. [2022]Head and neck intensity-modulated radiotherapy (IMRT) remains toxic, and cannot compensate for anatomic changes or tumor response that occur during treatment. Adaptive radiotherapy (ART) is a novel approach to correct for variations in geometry of tumor and bystander anatomy with repeated imaging-based modification of treatment delivery. Technical limitations have hampered introduction of ART into routine practice. This review summarizes investigational challenges impacting development of head and neck ART, describes findings from early clinical testing of an automated ART platform, and highlights emerging directions of ongoing research.
[Adaptative radiotherapy: The case for MRI-guided radiotherapy]. [2017]The concept of image-guided radiotherapy benefits from the development of magnetic resonance imaging (MRI) associated with different capacities of tissue analyses such as spectroscopy or diffusion analysis. The production of devices allowing the repositioning of patients through MRI represents a strong added value without delivering any additional dose to the patient while the optimization of the adaptative strategies are facilitated by a better contrast of the soft tissues compared to the scanner. The advantages of MRI are well demonstrated for brain tumours, head and neck carcinomas, pelvic tumors, mediastinal malignancies, gastrointestinal tract diseases. Adaptative radiotherapy inaugurates a new area of radiotherapy with different modalities. Several technological solutions are provided or discussed allowing the patients to benefit from thses new technologies as soon as possible.
MRI-guided radiotherapy for head and neck cancer: initial clinical experience. [2022]To report a single-institutional experience with the use of magnetic resonance imaging (MRI)-guided radiotherapy for cancers of the head and neck.
Magnetic resonance imaging guided reirradiation of recurrent and second primary head and neck cancer. [2020]To report a single-institutional experience using magnetic resonance imaging (MRI) guided radiation therapy for the reirradiation of recurrent and second cancers of the head and neck.
A daily end-to-end quality assurance workflow for MR-guided online adaptive radiation therapy on MR-Linac. [2020]Magnetic Resonance (MR)-guided online adaptive radiation therapy (MRgOART), enabled with MR-Linac, has potential to revolutionize radiation therapy. MRgOART is a complex process. This work is to introduce a comprehensive end-to-end quality assurance (QA) workflow in routine clinic for MRgOART with a high-magnetic-field MR-Linac.
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]This prospective study is, to our knowledge, the first report of daily adaptive radiation therapy (ART) for head and neck cancer (HNC) using a 1.5T magnetic resonance imaging-linear accelerator (MR-linac) with particular focus on safety and feasibility and dosimetric results of an online rigid registration-based adapt to position (ATP) workflow.
Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Urological Cancers: What Urologists Should Know. [2022]Magnetic resonance imaging (MRI)-guided radiotherapy allows for online adaptation of the radiation plan on the basis of anatomical and functional changes during treatment. MRI-guided radiotherapy holds significant promise for broadening the therapeutic window for multiple urological cancers.
Target Definition in MR-Guided Adaptive Radiotherapy for Head and Neck Cancer. [2022]In recent years, MRI-guided radiotherapy (MRgRT) has taken an increasingly important position in image-guided radiotherapy (IGRT). Magnetic resonance imaging (MRI) offers superior soft tissue contrast in anatomical imaging compared to computed tomography (CT), but also provides functional and dynamic information with selected sequences. Due to these benefits, in current clinical practice, MRI is already used for target delineation and response assessment in patients with head and neck squamous cell carcinoma (HNSCC). Because of the close proximity of target areas and radiosensitive organs at risk (OARs) during HNSCC treatment, MRgRT could provide a more accurate treatment in which OARs receive less radiation dose. With the introduction of several new radiotherapy techniques (i.e., adaptive MRgRT, proton therapy, adaptive cone beam computed tomography (CBCT) RT, (daily) adaptive radiotherapy ensures radiation dose is accurately delivered to the target areas. With the integration of a daily adaptive workflow, interfraction changes have become visible, which allows regular and fast adaptation of target areas. In proton therapy, adaptation is even more important in order to obtain high quality dosimetry, due to its susceptibility for density differences in relation to the range uncertainty of the protons. The question is which adaptations during radiotherapy treatment are oncology safe and at the same time provide better sparing of OARs. For an optimal use of all these new tools there is an urgent need for an update of the target definitions in case of adaptive treatment for HNSCC. This review will provide current state of evidence regarding adaptive target definition using MR during radiotherapy for HNSCC. Additionally, future perspectives for adaptive MR-guided radiotherapy will be discussed.
Magnetic Resonance-Guided Radiation Therapy for Head and Neck Cancers. [2023]Despite the significant evolution of radiation therapy (RT) techniques in recent years, many patients with head and neck cancer still experience significant toxicities during and after treatments. The increased soft tissue contrast and functional sequences of magnetic resonance imaging (MRI) are particularly attractive in head and neck cancer and have led to the increasing development of magnetic resonance-guided RT (MRgRT). This approach refers to the inclusion of the additional information acquired from a diagnostic or planning MRI in radiation treatment planning, and now extends to online high-quality daily imaging generated by the recently developed MR-Linac. MRgRT holds numerous potentials, including enhanced baseline and planning evaluations, anatomical and functional treatment adaptation, potential for hypofractionation, and multiparametric assessment of response. This article offers a structured review of the current literature on these established and upcoming roles of MRI for patients with head and neck cancer undergoing RT.