Shorter Radiation Schedule for Head and Neck Cancer

No longer recruiting at 3 trial locations

Overseen By Lynda N. Rath

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Chemotherapy, Immunotherapy, Hormonotherapy

Disqualifiers: Metastatic disease, Pregnancy, Others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 6-7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a shorter radiation schedule for treating head and neck cancer in individuals aged 70 and older. The goal is to determine if fewer radiation sessions can effectively treat the cancer while causing fewer side effects compared to the standard 6-7 week course. Researchers are testing two approaches: adjuvant hypofractionation for patients who have had surgery and definitive hypofractionation for those who have not. This trial may suit someone diagnosed with head and neck cancer who has not yet received chemotherapy or radiation. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve treatment options for older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does mention that concurrent chemotherapy, immunotherapy, or hormonotherapy is not allowed, so you may need to discuss your current treatments with the trial team.

What prior data suggests that this shorter radiation schedule is safe for head and neck cancer patients?

Research has shown that hypofractionated radiation therapy, which involves fewer but stronger radiation sessions, is generally safe for treating head and neck cancers. Studies have found that patients typically tolerate this therapy well, even when compared to more traditional methods.

For patients who have undergone surgery and are receiving additional hypofractionated radiation, the treatment remains safe with proper supportive care. Patients receive close monitoring and assistance in managing any side effects.

For those receiving hypofractionated radiation as their primary treatment without prior surgery, early results indicate it is safe and effective. Trials have shown that many patients experienced tumor shrinkage and pain relief. Importantly, this approach caused little to no difference in certain side effects, such as lung inflammation, compared to traditional radiation.

Overall, these findings suggest that hypofractionated radiation could be a safe and effective option for treating head and neck cancer, particularly for older patients who might benefit from shorter treatment times. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for head and neck cancer involve several weeks of radiation therapy, which can be quite taxing for patients. However, the treatment approach known as hypofractionated radiation therapy is unique because it delivers a higher dose of radiation over a shorter period, potentially reducing the overall treatment time. This shorter schedule is particularly promising as it might lessen the burden on patients by minimizing the time they spend in treatment while maintaining effectiveness. Researchers are excited about this approach because it could lead to quicker recovery times and improved quality of life for patients without compromising the efficacy of the treatment.

What evidence suggests that this trial's radiation treatments could be effective for head and neck cancer?

Research has shown that hypofractionated radiation therapy (HFRT) can effectively treat head and neck cancer. This method delivers larger doses of radiation over a shorter period. In this trial, participants will receive one of two types of HFRT. The "Definitive Hypofractionated Radiation Treatment" targets patients who haven't had surgery, and studies suggest it may better control cancer by reducing its size or spread. Meanwhile, the "Adjuvant Hypofractionated Radiation Treatment" is designed for those who have undergone surgery. It is considered safe and can shorten treatment time, making it easier to complete. A review of studies found that this shorter treatment is as effective as the traditional, longer radiation schedule in controlling cancer in the treated area. This shorter schedule might also lead to better survival rates and improved quality of life due to fewer hospital visits and side effects. ^{1 4 5 6 7}

Who Is on the Research Team?

Richard L. Bakst

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for people aged 70 or older with head and neck squamous cell carcinoma (HNSCC), including various stages except the most advanced. They must have a life expectancy over 12 weeks, be fit for radiation therapy, and not have had previous radiation or chemotherapy for HNSCC. Pregnant individuals, those with dementia unable to consent, other current cancers (with some exceptions), or connective tissue disorders are excluded.

Inclusion Criteria

I am not currently receiving chemotherapy.

Your doctor believes you have at least 3 months left to live.

My doctor says I'm not fit for certain treatments, and I have some limitations in daily activities.

Exclusion Criteria

I do not have conditions like Scleroderma that worsen with radiation.

I am currently receiving chemotherapy, immunotherapy, or hormone therapy.

I have had radiation therapy on my head or neck.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive short-course hypofractionated radiation therapy

6-7 weeks

Daily visits (5 days per week)

Follow-up

Participants are monitored for locoregional control and overall survival

1 year

Long-term follow-up

Participants' quality of life and disease-free survival are assessed

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Adjuvant hypofractionation
• Definitive Hypofractionation

Trial Overview The study tests a shorter schedule of radiation treatment called Hypofractionation in elderly patients with HNSCC. It aims to see if this approach can reduce side effects and improve completion rates compared to the standard daily treatments that last 6-7 weeks.

How Is the Trial Designed?

Group I: Definitive Hypofractionated Radiation Treatment Experimental Treatment 1 Intervention

Short course radiation therapy for patients who have not had surgery

Group II: Adjuvant Hypofractionated Radiation Treatment Experimental Treatment 1 Intervention

Short course radiation therapy for patients who have undergone surgery

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

In a study of 257 breast cancer patients treated with hypofractionated radiation therapy (HFRT), the 5-year overall survival rate was 86.6%, indicating that HFRT is effective for patients with breast cancer and nodal involvement.

The treatment was associated with manageable side effects, with no serious complications like cardiac issues or pneumonitis reported, although some patients experienced mild to moderate skin changes and lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Regional Nodal Irradiation for Women With Node-Positive Breast Cancer. Bellefqih, S., Elmajjaoui, S., Aarab, J., et al.[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]

Hypofractionated radiation therapy, which delivers fewer but larger doses of radiation over a shorter period, has shown comparable outcomes to conventional radiation in treating breast cancer, suggesting it could be an effective alternative.

Ongoing phase 3 trials are investigating hypofractionated whole breast irradiation and accelerated partial breast irradiation, which may lead to broader acceptance of these methods for early-stage breast cancer, although concerns about patient selection and late toxicity remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy in the treatment of early-stage breast cancer. Freedman, GM.[2021]

A twice-weekly hypofractionated palliative radiotherapy regimen of 32 Gy in 8 fractions was effective in providing symptom relief for patients with locally very advanced head and neck cancers, with 76.3% reporting improved pain and 42.8% showing reduced anxiety and depression after treatment.

The treatment demonstrated low acute toxicity, with only 1.2% of patients experiencing severe mucositis, making it a safe option for symptom management in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twice-weekly palliative radiotherapy for locally very advanced head and neck cancers. Murthy, V., Kumar, DP., Budrukkar, A., et al.[2022]

High-dose, hypofractionated radiotherapy (HFRT) demonstrated a high overall response rate of 79% and a one-year local-progression free rate of 50% in treating head-and-neck malignancies, based on a retrospective analysis of 48 patients.

The study found that delivering doses of 6Gray or higher per fraction improved locoregional control, and increased toxicity was not observed with doses of 8Gray or more, suggesting that HFRT can be both effective and safe for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose hypofractionated radiotherapy is effective and safe for tumors in the head-and-neck. Teckie, S., Lok, BH., Rao, S., et al.[2022]

Hypofractionated radiation therapy (HFRT) at a dose of 52.5 Gy over 15 fractions was found to be feasible and effective for selected elderly patients with newly diagnosed glioblastoma, showing a median overall survival of 8 months and a 12-month overall survival rate of 30%.

The study indicated that HFRT resulted in limited toxicity, with no increase in steroid use during treatment, and some patients even experienced a reduction in steroid requirements, suggesting a favorable safety profile for this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of hypofractionated radiation therapy in elderly patients with newly diagnosed glioblastoma with poor prognosis. Navarria, P., Pessina, F., Cozzi, L., et al.[2019]

In a study of 77 patients with head and neck cancer receiving palliative hypofractionated radiotherapy (52-56 Gy in 13-14 fractions), 45% showed a complete or partial tumor response two months after treatment, indicating good efficacy.

The treatment was generally well-tolerated, with 25% experiencing severe mucositis and 15% severe dermatitis, but patients with poor performance status had lower completion rates and worse outcomes, suggesting careful patient selection is crucial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Extended Hypofractionated Palliative Radiotherapy Regimen for Head and Neck Carcinomas. Laursen, M., Specht, L., Kristensen, CA., et al.[2022]

Hypofractionated radiotherapy is effective for early-stage head and neck cancers, allowing for shorter treatment times without increasing side effects, while advanced tumors require hyperfractionation for effective control.

The study highlights that the presence of cancer stem cells (CSCs) and the tumor's oxygen levels significantly influence the choice of radiotherapy schedule, indicating that more aggressive treatments may be necessary for tumors with low oxygenation and high CSC levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of hypofractionated radiotherapy in the management of head and neck cancer - a modelling approach. Marcu, LG., Marcu, D.[2020]

In a study of vulnerable elderly patients with locally advanced head and neck squamous cell carcinoma, hypofractionated radiotherapy combined with cetuximab resulted in no complete responses, with three patients showing partial response and three experiencing disease progression after treatment.

The treatment was associated with significant acute toxicities, including gastrointestinal issues and skin reactions, indicating that HFBRT may not be a safer option for this patient group, highlighting the need for further research to improve treatment outcomes and reduce side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy combined with cetuximab in vulnerable elderly patients with locally advanced head and neck squamous cell carcinoma. De Felice, F., Vetrone, L., Bulzonetti, N., et al.[2020]

In a phase 1 study involving 12 patients with resected head and neck squamous cell carcinoma, moderately hypofractionated radiation therapy (RT) was found to be well tolerated, with no dose-limiting toxicities reported.

The study determined that a dose of 44.4 Gy in 12 fractions was the maximum tolerated, but 46.5 Gy in 15 fractions was recommended for further testing due to better tolerability and equivalent effectiveness, indicating a promising approach to reduce treatment time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HYPORT: Phase 1 Study of 3-Week Hypofractionated Postoperative Radiation Therapy for Head and Neck Squamous Cell Carcinoma. Moon, DH., Avkshtol, V., Vo, D., et al.[2023]

Hypofractionated radiotherapy (HFRT) is a feasible and safe treatment option for older patients (mean age ≥65 years) with head and neck cancers, showing acceptable disease control and tolerability.

For older patients who are fit for radical treatments, a regimen of 55 Gy in 20 fractions is recommended as a valid alternative to standard fractionated radiotherapy, although the choice of regimen should be tailored to individual patient factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Radiotherapy in Head and Neck Cancer Elderly Patients: A Feasibility and Safety Systematic Review for the Clinician. Piras, A., Boldrini, L., Menna, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10982057/

Hypofractionated radiation therapy for head and neck ... Moreover, the higher biological effectiveness of HFRT may improve tumor control rates, potentially leading to enhanced survival outcomes.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1053429625000025

Hypofractionated Radiation Therapy in the Definitive ... Hypofractionated radiation in the definitive setting for HNSCCs has shown early safety and promise even using 2D techniques.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772906024003868

A phase I/II study evaluating the feasibility and safety of ... Hypofractionated radiotherapy (HFRT) can be safely delivered in post-operative oral cavity carcinomas. •. Adjuvant HFRT reduces the overall treatment time.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7526182/

an open-label randomized controlled study (HYPORT-Adjuvant) A meta-analysis of these trials has shown that hypofractionated radiotherapy is similar to conventionally fractionated radiotherapy in terms of locoregional ...

5. e-roj.org e-roj.org/journal/view.php?number=1588

Part 1. Brain and head and neck Hypofractionation offers advantages such as shorter treatment times, improved compliance, and under specific conditions, particularly in tumors ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10982054/

exploring efficacy and safety - Part 1. Brain and head and neck Hypofractionation offers advantages such as shorter treatment times, improved compliance, and under specific conditions, particularly in tumors ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04284540

NCT04284540 | Hypofractionated Radiotherapy in Elderly ... The purpose of this research study is to investigate a shorter radiation treatment schedule for head and neck cancers in patients 70 years of age and older.