Non Elective Vulnerable Elderly Radiotherapy

Squamous Cell Carcinoma of Head and Neck Clinical Trial

— NEVER  

Official title:

Non Elective Vulnerable Elderly Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04832555
• Other study ID #: NEVER
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2021
• Est. completion date: February 2026

Study information

• Verified date: April 2021
• Source: Azienda Ospedaliero Universitaria Policlinico Modena
• Contact: Pasquale Mighali, MD
• Phone: +39 0594225868
• Email: pasqualemighali[@]aou.mo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2026
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Squamous Cell Carcinoma of Head and Neck

Intervention

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.

Locations

Country	Name	City	State
Italy	AOUPoliclinicoModena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Policlinico Modena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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
Secondary	Cause-specific mortality rates	Patients who died from cancer/total amount	within 3 months after start of treatment
Secondary	overall survival	defined as the time from the date of randomization to the date of death for any cause	5 years
Secondary	progression free survival	per modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1	12 and 24 months
Secondary	G8 role	correlation between G8 pre-screening evaluation and toxicity	6 and 12 months