MRI-Guided Radiotherapy for Head and Neck Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Disqualifiers: Pregnancy, Prior radiotherapy, Metastatic disease, others
No Placebo Group
Approved in 6 Jurisdictions
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?
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.46789
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.26101112
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.
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
Trial 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 (Procedure)
- Magnetic Resonance Guidance (Procedure)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Adaptive Radiotherapy treatmentExperimental Treatment2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Moffitt Cancer CenterTampa, FL
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Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
References
Intensity-modulated radiation therapy for head and neck cancer: systematic review and meta-analysis. [2022]Intensity-modulated radiation therapy (IMRT) provides the possibility of dose-escalation with better normal tissue sparing. This study was performed to assess whether IMRT can improve clinical outcomes when compared with two-dimensional (2D-RT) or three-dimensional conformal radiation therapy (3D-CRT) in patients with head and neck cancer.
[Setup margin for head-and-neck cancer patients receiving 2D-2D and 3D image-guided intensity-modulated radiation therapy]. [2018]Image-guided intensity-modulated radiation therapy is essential for oncology treatment of head-and-neck cancer patients.
Intensity-modulated radiotherapy for carcinoma of the head and neck. [2019]Intensity-modulated radiotherapy (IMRT) is the next evolutionary step of three-dimensional conformal radiotherapy (3-DCRT). IMRT plans are generated with computer-optimized nonuniform radiation beam intensities incident on a target or patient. The dose distributions in IMRT show significantly higher conformality compared with other methods of external-beam radiation delivery, including conventional 3-DCRT. This significant conformality is advantageous in malignancies of the head and neck, where differential dosage is needed to deliver higher doses to the primary tumor and lower doses to areas of subclinical disease. Topics discussed in this review include target delineation, salivary gland sparing, and treatment of specific primary sites. Available data from the literature are presented, including patterns of failure after IMRT. To illustrate the potential role of IMRT in dose escalation and sparing of normal tissues, fractionation strategies in the definitive treatment of head and neck malignancies are presented. In addition, the role of IMRT in treatment of recurrent malignancies of the head and neck is explored. Finally, general concepts of helical tomotherapy are discussed.
Intensity-modulated radiation therapy in the treatment of head and neck cancer. [2018]Intensity-modulated radiation therapy (IMRT) is a new technical improvement of radiotherapy, in which computer-controlled treatment machines produce multiple beams of radiotherapy whose intensity is optimized to deliver a high dose of radiation to specified volumes, while reducing the dose to adjacent non-target organs. The potential benefits include the ability to deliver higher doses to the target with an improved safety than has previously been possible, and to reduce side effects and complications. Using IMRT to treat some head and neck cancers is especially attractive due to the close vicinity of the targets and many critical, dose-limiting and non-involved structures, and because of the lack of breathing-related motion. The main clinical uncertainties in the use of IMRT for head and neck cancer relate to uncertainties in the extent of radiation to the target areas. In addition, large volumes of adjacent, non-target tissue receive moderate to low radiation doses, raising concerns of increased risk of radiation-related carcinogenesis in young patients. Initial promising clinical data have emerged from IMRT treatment of several head and neck tumor sites.
[Intensity modulated radiation therapy]. [2015]The development and successful clinical use of intensity modulated radiation therapy (IMRT) is a significant advance in radiation therapy. IMRT is particularly effective for cancers in complex anatomic regions such as the head and neck, and prostate, because the target volumes are contiguous to organs at risk. The success of IMRT strongly depends on the precise contouring of the target volumes and organs at risk. A significant benefit of IMRT with regard to xerostomia and quality of life has been reported for head and neck cancer. For prostate cancer, IMRT can deliver a high total dose of 76-80 Gy to the target volume without serious late toxicities.
Intensity-modulated radiation therapy in the management of head and neck cancer. [2019]Intensity-modulated radiation therapy (IMRT) represents a potentially significant new advance in the radiotherapeutic treatment of head and neck cancer patients. The capacity of IMRT to produce highly conformal dose distributions affords the opportunity to decrease the spectrum of toxicities associated with head and neck radiation. This review updates recent advances regarding the use of this emerging technology.
Intensity-modulated radiotherapy for head and neck cancer. [2007]Intensity-modulated radiation therapy (IMRT) is a new radiation delivery technique that allows more precise delivery of radiation and optimization of the dose intensity to specific volumes while sparing the dose to critical normal structures. Using IMRT in head and neck cancers is attractive because of close proximity of the tumor targets to critical normal structures such as the spine, eyes, and parotid glands. IMRT has been shown in a number of clinical sites to improve local control and decrease side effects. Specifically, IMRT has shown the ability to preserve salivary function through sparing of the parotid glands. At the same time, there remain some uncertainties in terms of target delineation, secondary cancers, and side effects to swallowing function that may be increased with IMRT. Multi-institutional studies of IMRT are under way, and these studies, combined with refinements of the technique, should lead to continued improvement in the radiotherapeutic management of head and neck cancer.
Intensity-modulated radiation therapy: emerging cancer treatment technology. [2018]The use of intensity-modulated radiation therapy (IMRT) is rapidly advancing in the field of radiation oncology. Intensity-modulated radiation therapy allows for improved dose conformality, thereby affording the potential to decrease the spectrum of normal tissue toxicities associated with IMRT. Preliminary results with IMRT are quite promising; however, the clinical data is relatively immature and overall patient numbers remain small. High-quality IMRT requires intensive physics support and detailed knowledge of three-dimensional anatomy and patterns of tumour spread. This review focuses on basic principles, and highlights the clinical implementation of IMRT in head and neck and prostate cancer.
A phase I study of dose-escalated chemoradiation with accelerated intensity modulated radiotherapy in locally advanced head and neck cancer. [2007]Intensity modulated radiotherapy (IMRT) allows the delivery of higher and more homogeneous radiation dose to head and neck tumours. This study aims to determine the safety of dose-escalated chemo-IMRT for larynx preservation in locally advanced head and neck cancer.
Comparison of daily versus nondaily image-guided radiotherapy protocols for patients treated with intensity-modulated radiotherapy for head and neck cancer. [2022]The purpose of this study was to determine the feasibility of nondaily image-guided radiotherapy (RT) strategies with intensity-modulated radiotherapy (IMRT) for head and neck cancer.
Intensity-modulated radiation therapy for head and neck cancer. [2022]Intensity-modulated radiation therapy (IMRT) involves the delivery of optimized nonuniform beam intensities to the patient. In the head and neck region, there are many critical structures in close proximity to the target, with little influence from internal organ motion. Because IMRT produces tightly conformal doses and steep-dose gradients next to normal tissues, it provides the potential for organ sparing and improved tumor control. The dosimetric superiority of head and neck IMRT over conventional techniques has been demonstrated. The initial results of clinical IMRT studies showed reduction in xerostomia with no compromise in locoregional control if caution and appropriate knowledge are exercised in target determination and delineation.
Intensity-modulated Radiotherapy in Patients With Aggressive Extranodal Non-Hodgkin Lymphoma of the Head and Neck. [2021]Image-guided intensity-modulated radiotherapy (IG-IMRT) is increasingly being used to treat patients with head and neck malignancies. This analysis compared conventional radiotherapy (CRT) and IMRT outcomes for head and neck aggressive extranodal non-Hodgkin lymphomas (EN-NHL).