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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open: non elective irradiation | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non elective radiotherapy | Radiation | Simultaneous integrated boost on CTV volumes, delineated as per guidelines, with the exception of intermediate-low risk, where the CTVs are experimental. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| radiomics | evaluation of radiomics features in study population: using an automated high-throughput extraction of large amounts of quantitative features | through study completion, an average of 5 year |
Inclusion Criteria:
Exclusion Criteria:
Age less than 70 years
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pasquale Mighali, MD | Contact | +39 0594225868 | pasqualemighali@aou.mo.it | |
| Elisa D'Angelo, MD | Contact | +39 3934317599 | dangelo.elisa@aou.mo.it |
| Name | Affiliation | Role |
|---|---|---|
| Elisa D'Angelo | Azienda Ospedaliero Universitaria Policlinico Modena | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOUPoliclinicoModena | Recruiting | Modena | Italy |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 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 |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |