Shorter Radiation Schedule for Head and Neck Cancer

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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. Standard radiation treatment for head and neck patients normally requires that the patient travel to the hospital daily for 6-7 weeks to receive radiation treatment 5 days per week. This long course of radiation can lead to significant side effects resulting in some people being unable to complete the course of treatment. If this happens, and there are gaps in the radiation treatment, this can lead to worse outcomes.

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 data supports the effectiveness of the treatment for head and neck cancer?

Research suggests that high-dose hypofractionated radiotherapy (HFRT) can be effective and safe for treating head and neck tumors, although its safety and efficacy are still debated. Additionally, hypofractionated radiotherapy is becoming more popular in managing head and neck cancer, indicating its potential effectiveness. ^{1 2 3 4 5}

Is hypofractionated radiotherapy safe for head and neck cancer patients?

Hypofractionated radiotherapy (HFRT) has been studied for head and neck cancer, and while it can be effective, safety concerns exist, especially for older or vulnerable patients. Some studies report limited toxicity, but others note severe side effects like oral mucositis and skin reactions, indicating that more research is needed to ensure its safety for all patients. ^{1 6 7 8 9}

How is the treatment 'Definitive Hypofractionation' different from other treatments for head and neck cancer?

Definitive Hypofractionation is unique because it uses fewer, larger doses of radiation over a shorter period compared to traditional radiation therapy. This approach is being explored for its potential to effectively treat head and neck cancer while possibly reducing the overall treatment time. ^{1 2 3 10 11}

Research Team

Richard L. Bakst

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 (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]

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 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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

High-dose hypofractionated radiotherapy is effective and safe for tumors in the head-and-neck. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Twice-weekly palliative radiotherapy for locally very advanced head and neck cancers. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Phase II study of hypofractionated radiation therapy in elderly patients with newly diagnosed glioblastoma with poor prognosis. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

An Extended Hypofractionated Palliative Radiotherapy Regimen for Head and Neck Carcinomas. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Hypofractionated Radiotherapy in Head and Neck Cancer Elderly Patients: A Feasibility and Safety Systematic Review for the Clinician. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy combined with cetuximab in vulnerable elderly patients with locally advanced head and neck squamous cell carcinoma. [2020]

8. Greece pubmed.ncbi.nlm.nih.gov

Limited Toxicity of Hypofractionated Intensity Modulated Radiation Therapy for Head and Neck Cancer. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

HYPORT: Phase 1 Study of 3-Week Hypofractionated Postoperative Radiation Therapy for Head and Neck Squamous Cell Carcinoma. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

Hypofractionated Regional Nodal Irradiation for Women With Node-Positive Breast Cancer. [2022]