Status:
RECRUITING
Non Elective Vulnerable Elderly Radiotherapy
Lead Sponsor:
Azienda Ospedaliero Universitaria Policlinico Modena
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
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-infe...
Detailed Description
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, sc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04832555
Start Date
February 20 2021
End Date
February 1 2026
Last Update
April 6 2021
Active Locations (1)
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1
AOUPoliclinicoModena
Modena, Italy