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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Simultaneous integrated boost on CTV volumes, delineated as per guidelines, with the exception of intermediate-low risk, where the CTVs are experimental.
AOUPoliclinicoModena
Modena, Italy
RECRUITINGLoco-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.
Time frame: 24 months after the start of treatment
rate of severe sub-acute or late toxicity
assessment of toxicity according to CTCAE v5.0 scale
Time frame: at 6 and 12 months after the completion of radiotherapy
Cause-specific mortality rates
Patients who died from cancer/total amount
Time frame: 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
Time frame: 5 years
progression free survival
per modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
Time frame: 12 and 24 months
G8 role
correlation between G8 pre-screening evaluation and toxicity
Time frame: 6 and 12 months
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