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Non Elective Vulnerable Elderly Radiotherapy
RECRUITINGN/ASponsored by Azienda Ospedaliero Universitaria Policlinico Modena
Actively Recruiting
PhaseN/A
SponsorAzienda Ospedaliero Universitaria Policlinico Modena
Started2021-02-20
Est. completion2023-07
Eligibility
Age70 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04832555
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-inferior loco-regional control compared to similar historical cohorts.
Eligibility
Age: 70 Years+Healthy volunteers accepted
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
Conditions2
CancerSquamous Cell Carcinoma of Head and Neck
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Actively Recruiting
PhaseN/A
SponsorAzienda Ospedaliero Universitaria Policlinico Modena
Started2021-02-20
Est. completion2023-07
Eligibility
Age70 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04832555