Clinical trial NCT04832555: Non Elective Vulnerable Elderly Radiotherapy
Official title: Non Elective Vulnerable Elderly Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: Elderly
Vulnerable
Radiotherapy
Non-elective Radiotherapy
Lead sponsor: Azienda Ospedaliero Universitaria Policlinico Modena
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Loco-regional control
timeFrame: 24 months after the start of treatment
Secondary outcomes:
measure: rate of severe sub-acute or late toxicity
timeFrame: at 6 and 12 months after the completion of radiotherapy
measure: Cause-specific mortality rates
timeFrame: within 3 months after start of treatment
measure: overall survival
timeFrame: 5 years
measure: progression free survival
timeFrame: 12 and 24 months
measure: G8 role
timeFrame: 6 and 12 months
Other outcomes:
measure: radiomics
timeFrame: through study completion, an average of 5 year
Locations:
city: Modena
country: Italy
facility: AOUPoliclinicoModena
Study officials:
affiliation: Azienda Ospedaliero Universitaria Policlinico Modena
name: Elisa D'Angelo
role: STUDY_CHAIR
References: