What side effects are associated with this type of intervention?

Common treatments for Head and Neck Squamous Cell Carcinoma, such as radiation therapy (RT) and chemoradiation, are associated with several side effects. Acute side effects include mucositis, which can be severe and confluent, leading to difficulties in swallowing and the need for tube feeding. Long-term side effects can include late grade 3 and 4 toxicities such as ulceration, soft tissue necrosis, fibrosis, dysphagia, and osteoradionecrosis. The severity of these side effects can vary depending on the dose and duration of the treatment. For example, higher doses of RT are associated with higher rates of severe mucositis and long-term toxicities.

What prior FDA approvals exist?

The FDA has approved cetuximab, an EGFR-targeting monoclonal antibody, for the treatment of locoregionally advanced and metastatic HNSCC. This approval was based on a large international study demonstrating significant improvements in locoregional control and overall survival when cetuximab was added to definitive radiation therapy. Additionally, hypofractionated adjuvant radiotherapy is being studied to determine the safe reduction of treatment fractions in resected HNSCC patients with intermediate pathologic risk features, aiming to maintain efficacy while reducing treatment burden.

What other types of research exist?

Promising novel alternatives to reduction in treatment fractions for HNSCC patients include whole-neck irradiation, hypoxic radiosensitization, three-dimensional treatment planning, charged particle irradiation, and the combination of pembrolizumab plus cetuximab. Metronomic chemotherapy is also being investigated as a potential treatment strategy.

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Radiation Therapy

Reduced-Dose Radiotherapy for Head and Neck Cancer (HART-HN Trial)

N/A

Recruiting

Led By Musaddiq Awan, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

Patients must have at least 1 of the following intermediate risk factors for adjuvant radiation: Pathologic Node Positive Disease, Perineural Invasion, Oral cavity cancer with depth of invasion of at least 5 mm, Lymphovascular Space Invasion, Pathologic T3 or T4 disease

Patients 18 years or older with gross totally resected (R0 resection) Human papillomavirus (HPV) -negative squamous cell carcinoma of the head and neck

Must not have

Unstable angina and/or congestive heart failure requiring hospitalization within 3 months prior to Step 1 registration

Patients with prior radiation therapy to the head and neck

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

Summary

This trial is testing a new radiation treatment for patients with head and neck cancer after surgery. The goal is to see if this method is as safe and effective as the traditional longer course of treatment.

Who is the study for?

Adults with certain types of head and neck cancers that have been surgically removed but carry intermediate risk factors for recurrence. Participants must be in good general health, psychologically able to complete the study, not pregnant or breastfeeding, willing to use contraception if of childbearing potential, and without recent serious heart issues or other invasive malignancies.

What is being tested?

The trial is testing three different doses of radiation therapy (42 Gy, 39 Gy, and 32.5 Gy) given over fewer treatment sessions than usual to see which is safest for patients with resected head and neck squamous cell carcinoma who are at an intermediate risk of cancer returning.

What are the potential side effects?

Radiation therapy may cause side effects such as skin irritation at the treatment site, fatigue, dry mouth or throat discomfort due to inflammation in treated areas. Long-term risks include possible changes in skin texture or coloration and a slight increase in the chance of developing another cancer.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has one of the specific risk factors like spreading to lymph nodes or deep growth.

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I am 18 or older and had surgery to completely remove HPV-negative squamous cell carcinoma in my head or neck.

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I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

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

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I haven't been hospitalized for heart issues in the last 3 months.

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I have had radiation therapy to my head or neck.

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My body weight is 30 kg or less.

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My surgery left some cancer cells behind.

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My cancer has spread outside the lymph nodes.

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My cancer is HPV-positive squamous cell carcinoma.

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I haven't had cancer (except skin or early prostate cancer) in the last 3 years.

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I have received systemic therapy for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Dose-Limiting Toxicities

Maximum-tolerated Radiation Dose

Secondary study objectives

Functional Assessment of Cancer Therapies- Head and Neck (Emotional Well-being)

Functional Assessment of Cancer Therapies- Head and Neck (FACT-HN)

Functional Assessment of Cancer Therapies- Head and Neck (Functional Well-being)

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: 42 Gray (Gy) RadiationExperimental Treatment1 Intervention

42 gy of radiation therapy will be administered in 10 fractions.

Group II: 39 Gray (Gy) RadiationExperimental Treatment1 Intervention

39 gy of radiation therapy will be administered in 8 fractions.

Group III: 32.5 Gray (Gy) RadiationExperimental Treatment1 Intervention

32.5 gy of radiation therapy will be administered in 5 fractions.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include radiation therapy, chemotherapy, and surgery. Radiation therapy works by damaging the DNA of cancer cells, leading to their death. Chemotherapy uses cytotoxic drugs to target and kill rapidly dividing cells, including cancer cells. Surgery involves the physical removal of the tumor. The trial on reducing treatment fractions in radiation therapy is investigating whether fewer, higher doses of radiation can be safely administered, which could reduce treatment time and side effects. This is crucial for HNSCC patients as it may improve their quality of life and adherence to treatment.

Early (90-day) mortality after radical radiotherapy for head and neck squamous cell carcinoma: A population-based analysis.