Shorter Radiation Schedule for Head and Neck Cancer
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Must not be taking: Chemotherapy, Immunotherapy, Hormonotherapy
Disqualifiers: Metastatic disease, Pregnancy, Others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
16789How 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.
1231011Eligibility 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.
+9 more
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.
+5 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Definitive Hypofractionated Radiation TreatmentExperimental Treatment1 Intervention
Short course radiation therapy for patients who have not had surgery
Group II: Adjuvant Hypofractionated Radiation TreatmentExperimental Treatment1 Intervention
Short course radiation therapy for patients who have undergone surgery
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mount Sinai Downtown Union SquareNew York, NY
Mount Sinai HospitalNew York, NY
Mount Sinai ChelseaNew York, NY
Mount Sinai WestNew York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
References
High-dose hypofractionated radiotherapy is effective and safe for tumors in the head-and-neck. [2022]High-dose, hypofractionated radiotherapy (HFRT) is sometimes used to treat malignancy in the head-and-neck (HN), both in the curative and palliative setting. Its safety and efficacy have been reported in small studies and are still controversial.
Twice-weekly palliative radiotherapy for locally very advanced head and neck cancers. [2022]The purpose of the following study is to evaluate the efficacy of a twice-weekly hypofractionated palliative radiotherapy schedule in locally very advanced head and neck cancers.
The role of hypofractionated radiotherapy in the management of head and neck cancer - a modelling approach. [2020]Cancer stem cells (CSCs) and hypoxia are key contributors towards radioresistance and they influence the choice of radiotherapy schedule for optimal tumour control. Since hypofractionation is becoming more popular in head and neck cancer (HNC) management, the aim of this work is to use a modelling approach to evaluate the efficacy of hypofractionated radiotherapy on both early stage and advanced tumours.
Phase II study of hypofractionated radiation therapy in elderly patients with newly diagnosed glioblastoma with poor prognosis. [2019]To evaluate hypofractionated radiation therapy (HFRT) given at therapeutic effective doses in a phase II study. Endpoints were progression-free survival (PFS) rate, overall survival (OS), and incidence of toxicity.
An Extended Hypofractionated Palliative Radiotherapy Regimen for Head and Neck Carcinomas. [2022]Palliative radiotherapy to patients with head and neck cancer is often necessary, but there is a substantial variation in the treatment regimens reported in the literature, and consensus on the most appropriate schedules does not exist. In order to minimize acute toxicity while at the same time trying to achieve prolonged tumor control, a long hypofractionated regimen has been used routinely in Denmark. In the current retrospective study, we investigated the outcome in patients intended for palliative radiotherapy with this regimen.
Hypofractionated Radiotherapy in Head and Neck Cancer Elderly Patients: A Feasibility and Safety Systematic Review for the Clinician. [2022]Radiotherapy (RT) in the head and neck (H&N) site are undoubtedly the most challenging treatments for patients. Older and frail patients are not always able to tolerate it, and there are still no clear guidelines on the type of treatments to be preferred for them. The recommendations for Risk-Adapted H&N Cancer Radiation Therapy during the coronavirus disease 2019 (COVID-19) pandemic provided by the ASTRO-ESTRO consensus statement achieved a strong agreement about hypofractionated RT (HFRT). A systematic literature review was conducted in order to evaluate the feasibility and safety of HFRT for older patients affected by H&N malignancies.
Hypofractionated radiotherapy combined with cetuximab in vulnerable elderly patients with locally advanced head and neck squamous cell carcinoma. [2020]This study was designed to evaluate the objective response after hypofractionated radiotherapy (HFRT) combined with cetuximab (HFBRT) in vulnerable elderly patients with locally advanced head and neck squamous cell carcinoma (HNSCC). Vulnerable elderly patients with histologically proven HNSCC received HFRT (total dose 60 Gy, 3 Gy/fraction) with concurrent cetuximab (250 mg/m2 with a loading dose of 400 mg/m2 1 week before HFRT). Elderly patients were categorized as vulnerable based on mini-cog test and adult comorbidity evaluation-27 score. All patients completed the programmed HFRT and two patients received the planned cetuximab infusion. Severe acute toxicity, observed in four patients, was gastrointestinal (oral mucositis in four cases; nausea/vomiting in one case) and dermatological (acneiform eruption in three cases; radiation dermatitis in one case). Three serious adverse events were recorded in three out of six patients Overall, three patients had a partial response and three patients had progression disease 3 months after the end of the treatment. No complete response was observed. HFBRT seems to be not a safer alternative approach for vulnerable elderly patients with locally advanced HNSCC. Further prospective trials are needed to define better tumor control with less incidence of toxic effects in vulnerable elderly HNSCC patients.
Limited Toxicity of Hypofractionated Intensity Modulated Radiation Therapy for Head and Neck Cancer. [2022]Hypofractionated radiation therapy is not commonly used in head and neck cancers (HNC) due to increased toxicity observed in historical cohorts. This study reviews our institutional experience using hypofractionated intensity modulated radiation therapy (H-IMRT) for HNC.
HYPORT: Phase 1 Study of 3-Week Hypofractionated Postoperative Radiation Therapy for Head and Neck Squamous Cell Carcinoma. [2023]Shortening the overall radiation therapy (RT) treatment time has advantages in cost and treatment burden, but data on hypofractionated RT in head and neck squamous cell carcinoma are limited. This study assessed the safety of moderately hypofractionated RT in the postoperative setting.
Hypofractionated radiation therapy in the treatment of early-stage breast cancer. [2021]Hypofractionated radiation refers to the use of fewer, larger-dose radiation treatments that are usually given over a shorter time period compared to conventional radiation fraction sizes. Randomized trials of hypofractionated whole breast irradiation (WBI) have demonstrated comparable outcomes as conventional fractionation. For a higher-risk population for local recurrence, a phase 3 trial by the Radiation Therapy Oncology Group (RTOG) is currently studying hypofractionated WBI with a concurrent tumor bed boost over 3 weeks. Accelerated partial breast irradiation limits radiation to the region of the tumor bed for 1-3 weeks and is the subject of an ongoing randomized trial by the National Surgical Breast and Bowel Project and RTOG. Questions remain for hypofractionation about optimal patient selection, radiation techniques, and the risk of late toxicity. But results from current trials could make hypofractionation more widely accepted for patients with early-stage breast cancer.
Hypofractionated Regional Nodal Irradiation for Women With Node-Positive Breast Cancer. [2022]To evaluate the effect of hypofractionated radiation therapy (HFRT) of the breast/chest wall and regional nodes on overall survival (OS), disease-free survival (DFS), locoregional control and on treatment-related toxicity in patients with breast cancer and nodal involvement.