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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement in Mean OAR Dose Reduction

Secondary outcome measures

Percentage of patients achieving a complete anatomic response

Percentage of patients achieving a complete metabolic response

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

~220

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,457 Total Patients Enrolled

George Yang, MDPrincipal InvestigatorMoffitt Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently open for this research endeavor?

"According to clinicaltrials.gov, this trial is still searching for participants and was most recently updated on November 13th 2023. The study's original posting date was October 26th 2023."

Answered by AI

What is the projected total number of participants for this research endeavor?

"Affirmative. Clinicaltrials.gov hosts evidence that this investigation is actively searching for participants, with the first posting being made on October 26th 2023 and the last edit occurring November 13th of same year. The study requires 25 candidates to be recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot Trial of Adaptive Radiotherapy Boost for HNSCC

2023. "Pilot Trial of Adaptive Radiotherapy Boost for HNSCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06137274.

All > Hnscc