Hypofractionated IMRT for Head and Neck Cancer

Overseen By Sarah Neufeld, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Investigational agents

Disqualifiers: Distant metastasis, High risk factors, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new radiation therapy approach for head and neck cancer, assessing whether fewer, higher doses are as safe and effective as traditional treatments. The first phase evaluates patient tolerance to this method, while the second phase compares its effects on swallowing and overall effectiveness. This trial suits individuals who have undergone surgery for squamous cell carcinoma in the mouth or throat and have specific risk factors, such as larger tumors or affected lymph nodes. As a Phase 1 and Phase 2 trial, the research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot be on any other investigational agents for the treatment of the cancer under study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hypofractionated IMRT, a type of radiation therapy, is generally well-tolerated by patients with head and neck cancer. One study found that administering a dose of 50 Gy over 20 sessions is safe and does not cause significant side effects. This suggests that hypofractionated IMRT, which involves higher doses in fewer sessions, could be a safe treatment option for head and neck cancer.

IMRT targets tumors more precisely, helping to protect normal tissue and reduce side effects. This precision is a key reason for its safety in many patients. While the evidence is promising, discussing potential risks and side effects with a healthcare provider before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for head and neck cancer?

Researchers are excited about hypofractionated intensity-modulated radiation therapy (IMRT) for head and neck cancer because it offers a potentially faster treatment option compared to conventional radiotherapy. Traditional treatments often require longer durations, typically around 30 sessions. However, hypofractionated IMRT compresses the treatment into fewer sessions with higher doses per session, potentially improving patient convenience and reducing treatment time. This method is designed to deliver precise radiation to cancer cells while minimizing exposure to surrounding healthy tissue, which could lead to fewer side effects and improved outcomes. By exploring different dosing schedules, this approach aims to optimize the balance between effectiveness and safety.

What evidence suggests that hypofractionated IMRT could be an effective treatment for head and neck cancer?

Research has shown that a new type of targeted radiation therapy, called hypofractionated IMRT, holds promise for treating head and neck cancer. In this trial, participants will receive either hypofractionated radiotherapy or conventionally fractionated radiotherapy. One study found that doses of 50 Gy or more over 20 sessions are safe and cause only mild side effects. This method allows treatment to finish faster than traditional approaches. Another study supported its use, showing it works well with fewer side effects. This means patients might have a better experience while still receiving effective treatment. Overall, hypofractionated radiotherapy is becoming a popular choice because it is both efficient and safe. ^{6 7 8 9 10}

Who Is on the Research Team?

Dominic Moon, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with stage I-IVB squamous cell carcinoma of the oral cavity or related areas, who've had surgery but still have intermediate risk factors. They must be in fair health, able to consent, and use birth control if needed. Excluded are those with distant cancer spread, prior radiation in the area, severe illnesses that affect study compliance, pregnant/nursing women, high-risk surgical outcomes needing chemo, certain immune conditions or other cancers.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.

I agree to use birth control during the study.

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

My cancer is a stage I or II squamous cell carcinoma of the glottis.

My cancer has spread to distant parts of my body.

I need chemotherapy along with surgery due to high risk factors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Hypofractionated Radiation Therapy

Determine the maximum tolerated dose and tolerability of hypofractionated radiation therapy

3 months

Phase 2: Randomized Radiation Therapy

Participants are randomized to receive either conventionally fractionated or hypofractionated radiation therapy

3-6 weeks

Follow-up

Participants are monitored for safety, toxicity, and quality of life outcomes

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Intensity-modulated Radiation Therapy (IMRT)

Trial Overview

The HYPORT trial tests a shorter course of post-op radiation therapy (IMRT) for head and neck cancer patients. Phase 1 checks safety and tolerability to find the right dose; Phase 2 compares swallowing quality of life and effectiveness against standard longer-term radiation treatments.

How Is the Trial Designed?

Group I: Hypofractionated radiotherapy Experimental Treatment 1 Intervention

Dose and fractionation determined by Phase I: Level 1: 44.4 Gy in 12 fractions, 4 fractions/week Level 0: 46.5 Gy in 15 fractions, 5 fractions/week Level -1: 52 Gy in 20 fractions, 5 fractions/week Level -2: 50 Gy in 20 fractions, 5 fractions/week

Group II: Conventionally fractionated radiotherapy Active Control 1 Intervention

60 Gy in 30 fractions, 5 fractions/week

Intensity-modulated Radiation Therapy (IMRT) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Intensity-modulated Radiation Therapy for:

• Head and neck cancers
• Breast cancer
• Prostate cancer
• Rectal cancer

Approved in United States as Intensity-modulated Radiation Therapy for:

• Head and neck cancers
• Breast cancer
• Prostate cancer
• Rectal cancer

Approved in Canada as Intensity-modulated Radiation Therapy for:

• Head and neck cancers
• Breast cancer
• Prostate cancer
• Rectal cancer

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

In a study of 385 head and neck cancer patients treated with advanced radiotherapy techniques (IMRT/VMAT) over a median follow-up of 6.4 years, locoregional control rates were high, with 2- and 5-year rates of 78.2% and 74.2%, respectively, indicating effective treatment delivery.

The study found very few recurrences outside the high-dose treatment areas, suggesting that target volume definition and treatment delivery were accurate, which is crucial for improving patient outcomes in future research on dose escalation or proton therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrence Patterns After IMRT/VMAT in Head and Neck Cancer. Bollen, H., van der Veen, J., Laenen, A., et al.[2022]

A systematic review of 13 studies found that both volumetric-modulated arc therapy (VMAT) and intensity-modulated radiotherapy (IMRT) provide comparable dosimetric results for treating head and neck cancer, indicating that either technique can be effective.

VMAT may offer advantages such as better sparing of normal tissue, reduced treatment time, and fewer monitor units, although it also carries a risk of secondary cancer due to the higher number of monitor units compared to older techniques like 3D conformal radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric justification for the use of volumetric modulated arc therapy in head and neck cancer-A systematic review of the literature. Buciuman, N., Marcu, LG.[2022]

In a study of 56 patients with head and neck cancers treated with hypofractionated intensity modulated radiation therapy (H-IMRT), the two-year locoregional control rate was 87%, and the median overall survival was 46 months, indicating promising efficacy.

The treatment was well tolerated, with no severe grade 4 or 5 toxicities reported, and only 79% of patients experienced acute grade 2 or 3 toxicity, suggesting that H-IMRT is a safe option for patients with head and neck cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limited Toxicity of Hypofractionated Intensity Modulated Radiation Therapy for Head and Neck Cancer. Mayo, ZS., Ilori, EO., Matia, B., et al.[2022]

Volumetric Modulated Arc Therapy (VMAT) significantly reduces radiation exposure to critical organs, such as the parotid glands and oral cavity, compared to Intensity-Modulated Radiation Therapy (IMRT), with average doses decreasing from 27.2 Gy to 25.0 Gy and from 39.4 Gy to 36.7 Gy, respectively.

VMAT also offers a substantial reduction in treatment delivery time, averaging 5:54 minutes compared to 13:15 minutes for IMRT, enhancing patient comfort and potentially minimizing movement during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-institutional comparison of volumetric modulated arc therapy vs. intensity-modulated radiation therapy for head-and-neck cancer: a planning study. Holt, A., Van Gestel, D., Arends, MP., et al.[2022]

In a study of 102 patients with stage III-IV head and neck cancer treated with Volumetric Modulated Arc Therapy (VMAT) and Simultaneous Integrated Boost (SIB), the treatment demonstrated a good toxicity profile, with specific dose correlations to mucosal toxicity and salivary gland effects.

The treatment resulted in promising overall survival rates of 83% at 3 years and 73% at 5 years, along with disease-free survival rates of 71% at 3 years and 34% at 5 years, indicating effective long-term outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity profile and early clinical outcome for advanced head and neck cancer patients treated with simultaneous integrated boost and volumetric modulated arc therapy. Franzese, C., Fogliata, A., Clerici, E., et al.[2022]

Volumetric Intensity-Modulated Arc Therapy (VMAT) shows promising benefits for head and neck cancer patients by providing treatment plans that have similar conformity and better homogeneity compared to traditional Intensity-Modulated Radiotherapy (IMRT).

VMAT also allows for quicker treatment times and requires fewer monitor units (MUs), although more clinical data is needed to fully assess its side effects and overall efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is VMAT beneficial for patients undergoing radiotherapy to the head and neck? Osborn, J.[2018]

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]

Citations

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redjournal.org

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10547416/

Beyond the heart in hypofractionated radiotherapy and in ...

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uhcprovider.com

uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/intensity-modulated-radiation-therapy.pdf

Intensity-Modulated Radiation Therapy

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