25 Participants Needed

MRI-Guided Radiotherapy for Head and Neck Cancer

AA
KS
Overseen ByKevin Samnarine
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to determine if it is feasible to use magnetic resonance imaging (MRI) to adjust a portion of radiation therapy for patients with head and neck squamous cell carcinoma . The technique under study will be used to personalize the study treatment based on response, keeping all treatments within standard of care guidelines.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on a stable dose of a medication like warfarin and have no issues with blood clotting, you may still participate.

Is MRI-guided radiotherapy safe for humans?

Intensity-modulated radiation therapy (IMRT), a form of MRI-guided radiotherapy, is generally considered safe and can reduce side effects by precisely targeting tumors while sparing nearby healthy tissues. However, there are some uncertainties about potential side effects, such as impacts on swallowing and the risk of secondary cancers, especially in younger patients.12345

How is MRI-Guided Radiotherapy with IMRT different from other treatments for head and neck cancer?

MRI-Guided Radiotherapy with Intensity-modulated radiotherapy (IMRT) is unique because it delivers precise radiation doses that conform closely to the shape of the tumor, minimizing damage to nearby healthy tissues. This precision helps reduce side effects like xerostomia (dry mouth) while maintaining effective tumor control, which is a significant advantage over conventional radiation techniques.16789

What data supports the effectiveness of the treatment MRI-Guided Radiotherapy for Head and Neck Cancer?

Research shows that intensity-modulated radiation therapy (IMRT), a component of MRI-guided radiotherapy, is effective for head and neck cancer because it can deliver higher doses to the tumor while sparing healthy tissue, reducing side effects and improving quality of life.36101112

Who Is on the Research Team?

GY

George Yang, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with squamous cell carcinoma of the head and neck who haven't had surgery, radiotherapy, or systemic therapy for their cancer. They must be able to have MRIs (no pacemakers or certain metals in body), not pregnant, willing to follow study rules, and have a good performance status indicating they can carry out daily activities.

Inclusion Criteria

I am willing and able to follow all study rules and attend all appointments.
I am fully active or can carry out light work.
I have a confirmed diagnosis of squamous cell carcinoma in specific areas of my head or neck.
See 5 more

Exclusion Criteria

I have received radiation or systemic therapy for my head or neck cancer.
I have had surgery to remove my cancer.
My cancer has spread to distant parts of my body.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo adaptive radiotherapy boost for head/neck squamous cell carcinomas, with MR simulation for boost treatment planning.

10 weeks
Weekly visits for treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months

What Are the Treatments Tested in This Trial?

Interventions

  • Intensity-modulated radiotherapy
  • Magnetic Resonance Guidance
Trial Overview The trial tests if MRI can help adjust radiation therapy doses during treatment for head and neck cancer. The goal is to personalize the radiation dose based on how well the tumor responds using intensity-modulated radiotherapy within standard care guidelines.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Adaptive Radiotherapy treatmentExperimental Treatment2 Interventions

Intensity-modulated radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

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Approved in European Union as IMRT for:
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Approved in United States as IMRT for:
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Approved in Canada as IMRT for:
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Approved in Japan as IMRT for:
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Approved in China as IMRT for:
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Approved in Switzerland as IMRT for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

Published Research Related to This Trial

Intensity-modulated radiation therapy (IMRT) significantly reduces the incidence of severe xerostomia (dry mouth) in patients with head and neck cancer compared to traditional 2D and 3D radiation therapies, as shown in a review of five randomized trials involving 871 patients.
IMRT provides these benefits without compromising loco-regional control or overall survival rates, indicating it is a safer and more effective option for managing head and neck cancers.
Intensity-modulated radiation therapy for head and neck cancer: systematic review and meta-analysis.Marta, GN., Silva, V., de Andrade Carvalho, H., et al.[2022]
Both MV-kV and CBCT imaging modalities produced similar setup error measurements for head-and-neck cancer patients, indicating that either method can be effectively used for image-guided radiation therapy.
MV-kV imaging was significantly faster and delivered a lower radiation dose (6.88 mGy) compared to CBCT (17.2 mGy), suggesting it could be a suitable alternative when reduced imaging time is necessary.
[Setup margin for head-and-neck cancer patients receiving 2D-2D and 3D image-guided intensity-modulated radiation therapy].KovΓ‘cs, P., Szita, E., Schvarcz, K., et al.[2018]
Intensity-modulated radiotherapy (IMRT) offers significantly higher conformality in dose distribution compared to conventional 3-D conformal radiotherapy (3-DCRT), making it particularly beneficial for treating head and neck cancers where precise dosage is crucial.
IMRT allows for higher doses to be delivered to primary tumors while sparing surrounding healthy tissues, which can improve treatment outcomes and reduce side effects, especially in the context of recurrent head and neck malignancies.
Intensity-modulated radiotherapy for carcinoma of the head and neck.PeΓ±agarΓ­cano, JA., Papanikolaou, N.[2019]

Citations

Intensity-modulated radiation therapy for head and neck cancer: systematic review and meta-analysis. [2022]
[Setup margin for head-and-neck cancer patients receiving 2D-2D and 3D image-guided intensity-modulated radiation therapy]. [2018]
Intensity-modulated radiotherapy for carcinoma of the head and neck. [2019]
Intensity-modulated radiation therapy in the treatment of head and neck cancer. [2018]
[Intensity modulated radiation therapy]. [2015]
Intensity-modulated radiation therapy in the management of head and neck cancer. [2019]
Intensity-modulated radiotherapy for head and neck cancer. [2007]
Intensity-modulated radiation therapy: emerging cancer treatment technology. [2018]
A phase I study of dose-escalated chemoradiation with accelerated intensity modulated radiotherapy in locally advanced head and neck cancer. [2007]
10.United Statespubmed.ncbi.nlm.nih.gov
Comparison of daily versus nondaily image-guided radiotherapy protocols for patients treated with intensity-modulated radiotherapy for head and neck cancer. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Intensity-modulated radiation therapy for head and neck cancer. [2022]
Intensity-modulated Radiotherapy in Patients With Aggressive Extranodal Non-Hodgkin Lymphoma of the Head and Neck. [2021]
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