Adaptive Radiation Therapy for Anal Cancer
(MAESTRO Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University Health Network, Toronto
Disqualifiers: Previous chemotherapy, Previous RT, Others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The proposed study is a phase II, single arm, open-label trial of MR-guided radiation therapy (RT) with risk stratified RT dose selection in patients with anal cancer. Based on previous data, a risk adaptive treatment approached is proposed in 4 groups: Low risk, standard risk, intermediate risk, and high risk. Human papillomavirus (HPV) DNA will be analyzed to identify novel biomarkers that predict chemoradiotherapy (CRT) response and toxicity.
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 coordinators or your doctor.
What data supports the effectiveness of the treatment MR-Adaptive Radiation Therapy for anal cancer?
Research shows that MR-guided adaptive radiation therapy has been used effectively in other cancers, like prostate and cervical cancer, by allowing precise targeting and adaptation of treatment plans. This suggests it could also be beneficial for anal cancer by improving treatment accuracy and potentially reducing side effects.
12345Is MR-guided adaptive radiation therapy safe for humans?
MR-guided adaptive radiation therapy (MRgRT) has been used successfully in adults for various conditions, showing potential for reducing side effects. It offers improved imaging without extra radiation exposure, which suggests it is generally safe for human use.
12678What makes MR-Adaptive Radiation Therapy unique for treating anal cancer?
MR-Adaptive Radiation Therapy is unique because it uses real-time MRI imaging to precisely target the cancer, allowing for daily adjustments to the treatment plan based on changes in the tumor's size or position. This approach can potentially improve accuracy and reduce side effects compared to traditional radiation therapy.
12349Eligibility Criteria
This trial is for adults over 18 with a confirmed diagnosis of anal squamous cell carcinoma, at clinical stage T1-4 N0-1 M0. They must be fit for definitive radiation or chemoradiation therapy and have an ECOG performance status of 0-2. Excluded are those who've had prior treatments for anal cancer, previous pelvic radiation that overlaps with this study's area, or other cancers unless they're low-risk and disease-free for two years.Inclusion Criteria
I am eligible for targeted radiation or combined chemotherapy and radiation treatment.
My cancer is in an early or locally advanced stage but hasn't spread far.
I can take care of myself and am up and about more than half of my waking hours.
+2 more
Exclusion Criteria
I have had treatment for anal cancer before.
I have not had radiation therapy in the abdomino-pelvic area that overlaps with this study's area.
I've been cancer-free for 2 years, or I had certain skin or cervical cancers treated within 5 years.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo MR-guided radiation therapy with risk-stratified dose selection and chemotherapy cycles based on clinical and biological biomarkers
Varies based on risk group
Follow-up
Participants are monitored for safety and effectiveness after treatment, including completion of questionnaires and clinic visits
5 years
Participant Groups
The study tests MR-guided radiation therapy in patients with anal cancer using a risk-adaptive approach to determine treatment doses across four groups: low, standard, intermediate, and high risk. It also aims to identify new biomarkers from HPV DNA that could predict how well patients respond to the treatment and their likelihood of experiencing side effects.
MR-Adaptive Radiation Therapy is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as MR-Adaptive Radiation Therapy for:
- Anal cancer
🇺🇸 Approved in United States as MR-Adaptive Radiation Therapy for:
- Anal cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Allegheny Health NetworkPittsburgh, PA
Medical College of Wisconsin Cancer CenterMilwaukee, WI
Princess Margaret Cancer CentreToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
Medical College of Wisconsin Cancer Center, Allegheny Health Network, Austin HealthCollaborator
Medical College of WisconsinCollaborator
References
Online Magnetic Resonance Image Guided Adaptive Radiation Therapy: First Clinical Applications. [2022]To demonstrate the feasibility of online adaptive magnetic resonance (MR) image guided radiation therapy (MR-IGRT) through reporting of our initial clinical experience and workflow considerations.
Magnetic Resonance-Guided Prostate Stereotactic Body Radiation Therapy With Daily Online Plan Adaptation: Results of a Prospective Phase 1 Trial and Supplemental Cohort. [2022]Stereotactic magnetic resonance (MR)-guided adaptive radiation therapy (SMART) for prostate cancer allows for MR-based contouring, real-time MR motion management, and daily plan adaptation. The clinical and dosimetric benefits associated with prostate SMART remain largely unknown.
Magnetic resonance-guided adaptive radiotherapy: a solution to the future. [2022]Magnetic resonance imaging-guided adaptive radiotherapy would make available the best in anatomical and functional imaging during the course of radiation therapy. The possible methodology of magnetic resonance imaging-guided adapted radiotherapy and possible clinical applications are discussed.
Adaptive Magnetic Resonance-Guided External Beam Radiation Therapy for Consolidation in Recurrent Cervical Cancer. [2022]Adaptive magnetic resonance (MR)-guided brachytherapy takes an important place as consolidation within the care of cervical malignancies, but may be impracticable in some unusual cases. This work aimed to present the case of adaptive MR-guided external beam radiation therapy (aMRgRT) used as a boost in a recurrence of cervical cancer.
Follow-up imaging of anal cancer after treatment. [2023]Anal cancer treatment response assessment can be challenging with both magnetic resonance imaging (MRI) and clinical evaluation considered essential. MRI, in particular, has shown to be useful for the assessment of treatment response, the detection of recurrent disease in follow up and surveillance, and the evaluation of possible post-treatment complications as well as complications from the tumor itself. In this review, we focus on the role of imaging, mainly MRI, in anal cancer treatment response assessment. We also describe the treatment complications that can occur, and the imaging findings associated with those complications.
The potential role of MR-guided adaptive radiotherapy in pediatric oncology: Results from a SIOPE-COG survey. [2022]Magnetic resonance guided radiotherapy (MRgRT) has been successfully implemented for several routine clinical applications in adult patients. The purpose of this study is to map the potential benefit of MRgRT on toxicity reduction and outcome in pediatric patients treated with curative intent for primary and metastatic sites.
Magnetic Resonance Image-Guided Radiotherapy (MRIgRT): A 4.5-Year Clinical Experience. [2023]Magnetic resonance image-guided radiotherapy (MRIgRT) has been clinically implemented since 2014. This technology offers improved soft-tissue visualisation, daily imaging, and intra-fraction real-time imaging without added radiation exposure, and the opportunity for adaptive radiotherapy (ART) to adjust for anatomical changes. Here we share the longest single-institution experience with MRIgRT, focusing on trends and changes in use over the past 4.5 years.
Poster - Thur Eve - 05: Safety systems and failure modes and effects analysis for a magnetic resonance image guided radiation therapy system. [2019]An online Magnetic Resonance guided Radiation Therapy (MRgRT) system is under development. The system is comprised of an MRI with the capability of travel between and into HDR brachytherapy and external beam radiation therapy vaults. The system will provide on-line MR images immediately prior to radiation therapy. The MR images will be registered to a planning image and used for image guidance. With the intention of system safety we have performed a failure modes and effects analysis.
[Image-guided and adaptive radiotherapy]. [2012]Image-guided radiotherapy (IGRT) aims to take into account anatomical variations occurring during irradiation by visualization of anatomical structures. It may consist of a rigid registration of the tumour by moving the patient, in case of prostatic irradiation for example. IGRT associated with intensity-modulated radiotherapy (IMRT) is strongly recommended when high-dose is delivered in the prostate, where it seems to reduce rectal and bladder toxicity. In case of significant anatomical deformations, as in head and neck tumours (tumour shrinking and decrease in volume of the salivary glands), replanning appears to be necessary, corresponding to the adaptive radiotherapy. This should ideally be "monitored" and possibly triggered based on a calculation of cumulative dose, session after session, compared to the initial planning dose, corresponding to the concept of dose-guided adaptive radiotherapy. The creation of "planning libraries" based on predictable organ positions (as in cervical cancer) is another way of adaptive radiotherapy. All of these strategies still appear very complex and expensive and therefore require stringent validation before being routinely applied.