Non Elective Vulnerable Elderly Radiotherapy

Study Overview
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Brief Summary
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To evaluate whether patients defined non-fit for curative non-surgical radio-chemotherapy and therefore treated with RT alone addressed only to non-elective sites of disease, could obtain a non-inferior loco-regional control compared to similar historical cohorts.

Detailed Description
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The current standard approach for head and neck malignancies cannot be considered the gold standard for elderly patients, except in carefully selected cases. Given the relevance of this population, scientific societies also suggest to propose prospective studies for this subset of frail patients (European Organization for Research and treatment of cancer (EORTC), European Society for Medical oncology (ESMO)). In addition, it is necessary to collect data on specific categories, which are as homogeneous as possible. Therefore, the purpose of this study is to evaluate efficacy and safety of a tailored RT approach administered with a curative intent in a subset of frails elderly patients not candidates neither to standard concurrent RT-CT / RT-cetuximab nor to palliative treatment/best supportive care.

Official Title
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Non Elective Vulnerable Elderly Radiotherapy

Conditions
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Squamous Cell Carcinoma of Head and Neck

Intervention / Treatment
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* Radiation: Non elective radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: locally advanced non-metastatic HNSCC patients older than 70 years Primary tumor clinically and radiologically detectable and measurable (staging according to ed. TNM VII and also VIII. patients defined by the tumor board (ENT, Oncologist, Radiotherapist, Nutritionist) as 1) not eligibles for RTCT / RT-cetuximab treatment 2) not amenable to radical surgery and 3) not candidates for treatments with palliative intent/best supportive care Availability of staging with CT/PET for distant metastasis and CT/MRI for primary tumor Karnofsky performance status (KPS) ≥60/100 Oropharynx , Hypopharynx and Larynx, Oral cavity: stage III and IV and Unknown primitive P16-POSITIVE Exclusion Criteria: Age less than 70 years Staging exams done 45 days before the date of the beginning of the treatment Subsites: nasopharynx, salivary glands, paranasal sinuses. Metastatic disease Gross total excision All subsites concerned if N3. Squamous cell neoplasms of the glottic larynx T1-T2 N0. Unknown primary HPV negative or EBV positive. Presence of distant metastases or sub-clavicular lymphadenopathies. Previous surgery on T and/or N except diagnostic tonsillectomy. 3D-conformational radiotherapy technique

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open: non elective irradiation<br>Patients within inclusion criteria will be enrolled in the experimental treatment: a radiation therapy addressed to non elective site of disease and with a simultaneous integrated boost | Radiation: Non elective radiotherapy<br>* Simultaneous integrated boost on CTV volumes, delineated as per guidelines, with the exception of intermediate-low risk, where the CTVs are experimental.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loco-regional control | clinical or radiological (RECIST 1.1) disease progression from end of treatment with tumor present, or to the date of salvage surgery of primary tumor with tumor present performed for clinical or radiological (RECIST 1.1) disease progression, whichever comes first. | 24 months after the start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of severe sub-acute or late toxicity | assessment of toxicity according to CTCAE v5.0 scale | at 6 and 12 months after the completion of radiotherapy | 
| Cause-specific mortality rates | Patients who died from cancer/total amount | within 3 months after start of treatment | 
| overall survival | defined as the time from the date of randomization to the date of death for any cause | 5 years | 
| progression free survival | per modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 | 12 and 24 months | 
| G8 role | correlation between G8 pre-screening evaluation and toxicity | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Vulnerable, Radiotherapy, Non-elective Radiotherapy