Non Elective Vulnerable Elderly Radiotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Loco-regional control
Study Overview
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-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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 N
- •Squamous cell neoplasms of the glottic larynx T1-T2 N
- •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
Outcomes
Primary Outcomes
Loco-regional control
Time Frame: 24 months after the start of treatment
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.
Secondary Outcomes
- Cause-specific mortality rates(within 3 months after start of treatment)
- progression free survival(12 and 24 months)
- overall survival(5 years)
- G8 role(6 and 12 months)
- rate of severe sub-acute or late toxicity(at 6 and 12 months after the completion of radiotherapy)
Investigators
Elisa D'angelo
Medical Doctor, MD
Azienda Ospedaliero Universitaria Policlinico Modena