NCT04832555

Non Elective Vulnerable Elderly Radiotherapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Azienda Ospedaliero Universitaria Policlinico Modena · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

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, 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.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
RADIATION	Non elective radiotherapy	Simultaneous integrated boost on CTV volumes, delineated as per guidelines, with the exception of intermediate-low risk, where the CTVs are experimental.

Timeline

• Start date: 2021-02-20
• Primary completion: 2023-07-01
• Completion: 2026-02-01
• First posted: 2021-04-06
• Last updated: 2021-04-06

Locations

1 site across 1 country: Italy