MRI-Guided Radiotherapy for Head and Neck Cancer

Overseen By Kevin Samnarine

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Pregnancy, Prior radiotherapy, Metastatic disease, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

25 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

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. ^{2 6 10 11 12}

Research Team

George Yang, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Adaptive Radiotherapy treatment Experimental Treatment 2 Interventions

Patients will undergo adaptive radiotherapy boost for head/neck squamous cell carcinomas. A base conventional IMRT plan of 46-50Gy in 2 Gy to gross disease in the primary/nodes and 41.4-45 Gy in 1.8 Gy to the elective nodes per fraction will be utilized. The MR simulation will be utilized for boost treatment planning. Patients will receive their 6th fraction of the week on the adaptive platform treating the gross disease until completion of the base plan to 20 Gy in 2Gy daily fractions (10 fractions). Each ART treatment will be recontoured/replanned by the treating head/neck radiation oncologist as deemed clinically or dosimetrically necessary.

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

Approved in European Union as IMRT for:

• Head and neck cancers
• Brain tumors
• Prostate cancer

Approved in United States as IMRT for:

• Head and neck cancers
• Brain tumors
• Prostate cancer
• Breast cancer

Approved in Canada as IMRT for:

• Head and neck cancers
• Brain tumors
• Prostate cancer

Approved in Japan as IMRT for:

• Head and neck cancers
• Brain tumors
• Prostate cancer

Approved in China as IMRT for:

• Head and neck cancers
• Brain tumors
• Prostate cancer

Approved in Switzerland as IMRT for:

• Head and neck cancers
• Brain tumors
• Prostate cancer

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Setup margin for head-and-neck cancer patients receiving 2D-2D and 3D image-guided intensity-modulated radiation therapy]. Kovács, 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy for carcinoma of the head and neck. Peñagarícano, JA., Papanikolaou, N.[2019]

Intensity-modulated radiation therapy (IMRT) allows for higher doses of radiation to be delivered precisely to cancerous areas while minimizing exposure to surrounding healthy tissues, which can improve safety and reduce side effects.

IMRT is particularly beneficial for treating head and neck cancers due to the close proximity of tumors to critical structures, although there are concerns about the potential long-term risks of radiation exposure to non-target tissues, especially in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy in the treatment of head and neck cancer. Eisbruch, A.[2018]

Intensity modulated radiation therapy (IMRT) represents a major advancement in treating cancers located near sensitive organs, such as those in the head and neck and prostate, by allowing for precise targeting of tumor volumes.

IMRT has been shown to significantly reduce xerostomia (dry mouth) and improve quality of life for head and neck cancer patients, while also enabling high radiation doses (76-80 Gy) for prostate cancer without causing serious late toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intensity modulated radiation therapy]. Nishimura, Y.[2015]

Intensity-modulated radiation therapy (IMRT) shows promise in treating head and neck cancer by delivering precise radiation doses, which may reduce side effects compared to traditional methods.

While advancements in IMRT techniques and target selection are being made, there is still a lack of mature clinical data to fully establish its safety and efficacy in head and neck cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy in the management of head and neck cancer. Hong, TS., Tomé, WA., Harari, PM.[2019]

Intensity-modulated radiation therapy (IMRT) allows for more precise radiation delivery in head and neck cancers, improving local control of tumors while minimizing damage to critical structures like the spine and parotid glands.

IMRT has been shown to preserve salivary function by sparing the parotid glands, although there are ongoing concerns about potential side effects, such as difficulties with swallowing and the risk of secondary cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy for head and neck cancer. Caglar, HB., Allen, AM.[2007]

Intensity-modulated radiation therapy (IMRT) offers improved dose targeting, which may reduce normal tissue damage compared to traditional radiation methods, making it a promising option in radiation oncology.

While preliminary results for IMRT in treating head and neck and prostate cancers are encouraging, the clinical data is still developing, and the number of patients studied remains relatively small.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy: emerging cancer treatment technology. Hong, TS., Ritter, MA., Tomé, WA., et al.[2018]

A study involving 30 patients with advanced laryngeal cancer showed that dose-escalated chemo-IMRT is safe and feasible, with no acute grade 4 toxicities observed and good compliance to treatment.

Complete response rates were high, with 80% in the lower dose group and 87% in the higher dose group, indicating that higher radiation doses can be delivered without significantly increasing acute toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I study of dose-escalated chemoradiation with accelerated intensity modulated radiotherapy in locally advanced head and neck cancer. Guerrero Urbano, T., Clark, CH., Hansen, VN., et al.[2007]

In a study of 103 head and neck cancer patients using intensity-modulated radiotherapy (IMRT), less-than-daily image-guided radiotherapy (RT) strategies showed a high risk of geometric misses, particularly with 3-mm uncertainty margins, where misses ranged from 15.7% to 50.5% depending on the imaging frequency.

To reduce the risk of treatment misses, the study suggests that less-than-daily RT protocols should use at least 5-mm margins, as this significantly lowers the incidence of geometric errors.

NCBI (Pubmed)

pubmed.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. Yu, Y., Michaud, AL., Sreeraman, R., et al.[2022]

Intensity-modulated radiation therapy (IMRT) offers improved tumor control in head and neck cancer by delivering optimized, nonuniform radiation doses that spare surrounding healthy tissues.

Clinical studies have shown that IMRT significantly reduces the incidence of xerostomia (dry mouth) without compromising the effectiveness of cancer treatment, provided that careful planning and target delineation are followed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy for head and neck cancer. Ozyigit, G., Yang, T., Chao, KS.[2022]

In a study of 48 patients with aggressive extranodal non-Hodgkin lymphomas, those treated with image-guided intensity-modulated radiotherapy (IG-IMRT) showed a higher overall response rate (85%) compared to those receiving conventional radiotherapy (CRT) (73%).

IG-IMRT was associated with fewer acute and chronic side effects, suggesting a better safety profile while also indicating a trend towards improved survival outcomes, although the difference in 5-year overall survival rates was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated Radiotherapy in Patients With Aggressive Extranodal Non-Hodgkin Lymphoma of the Head and Neck. Eismann, J., Elsayad, K., Rolf, D., et al.[2021]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy for head and neck cancer: systematic review and meta-analysis. [2022]

2. Hungary pubmed.ncbi.nlm.nih.gov

[Setup margin for head-and-neck cancer patients receiving 2D-2D and 3D image-guided intensity-modulated radiation therapy]. [2018]

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

Intensity-modulated radiotherapy for carcinoma of the head and neck. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy in the treatment of head and neck cancer. [2018]

5. Japan pubmed.ncbi.nlm.nih.gov

[Intensity modulated radiation therapy]. [2015]

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

Intensity-modulated radiation therapy in the management of head and neck cancer. [2019]

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

Intensity-modulated radiotherapy for head and neck cancer. [2007]

8. England pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy: emerging cancer treatment technology. [2018]

9. Ireland pubmed.ncbi.nlm.nih.gov

A phase I study of dose-escalated chemoradiation with accelerated intensity modulated radiotherapy in locally advanced head and neck cancer. [2007]

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

Intensity-modulated radiation therapy for head and neck cancer. [2022]

12. Greece pubmed.ncbi.nlm.nih.gov

Intensity-modulated Radiotherapy in Patients With Aggressive Extranodal Non-Hodgkin Lymphoma of the Head and Neck. [2021]