Non Elective Vulnerable Elderly Radiotherapy

Not Applicable

Recruiting

• Conditions: Squamous Cell Carcinoma of Head and Neck
• Interventions: Radiation: Non elective radiotherapy

• Registration Number: NCT04832555
• Lead Sponsor: Azienda Ospedaliero Universitaria Policlinico Modena

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 Timeline

• Study Start: 2021-02-20
• Study First Submitted: 2021-03-05
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-01
• Last Update Submitted: 2021-04-01
• Study First Posted: 2021-04-06
• Last Update Posted: 2021-04-06
• Primary Completion: 2023-07
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open: non elective irradiation	Non elective radiotherapy	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

Primary Outcome Measures

Name	Time	Method
Loco-regional control	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 Outcome Measures

Name	Time	Method
rate of severe sub-acute or late toxicity	at 6 and 12 months after the completion of radiotherapy	assessment of toxicity according to CTCAE v5.0 scale
Cause-specific mortality rates	within 3 months after start of treatment	Patients who died from cancer/total amount
progression free survival	12 and 24 months	per modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
overall survival	5 years	defined as the time from the date of randomization to the date of death for any cause
G8 role	6 and 12 months	correlation between G8 pre-screening evaluation and toxicity

Trial Locations

Locations (1)

AOUPoliclinicoModena; 🇮🇹 Modena, Italy