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Procedure

MRI-Guided Radiotherapy for Head and Neck Cancer

N/A

Recruiting

Led By George Yang, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0, 1

Patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or unknown primary in the neck

Must not have

Patients who have had prior radiotherapy to the head and neck or prior systemic therapy for the index cancer

Patients who had undergone definitive surgery for the index cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 months

Awards & highlights

No Placebo-Only Group

Summary

This trial examines if MRI can be used to personalize radiation therapy for head and neck cancer, while following standard care guidelines.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Intensity-modulated radiotherapy may cause skin redness, irritation at the treatment site, fatigue, dry mouth or throat discomfort due to exposure of healthy tissues around tumors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I have a confirmed diagnosis of squamous cell carcinoma in specific areas of my head or neck.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received radiation or systemic therapy for my head or neck cancer.

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I have had surgery to remove my cancer.

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My cancer has spread to distant parts of my body.

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I do not have any ongoing illnesses or social situations that would prevent me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement in Mean OAR Dose Reduction

Secondary study objectives

Percentage of patients achieving a complete anatomic response

Percentage of patients achieving a complete metabolic response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity-modulated radiotherapy

2010

Completed Phase 2

~330

0 / 6Eligibility criteria met