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Non Elective Vulnerable Elderly Radiotherapy (NEVER)

Primary Purpose

Squamous Cell Carcinoma of Head and Neck

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Non elective radiotherapy
Sponsored by
Azienda Ospedaliero Universitaria Policlinico Modena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Head and Neck focused on measuring Elderly, Vulnerable, Radiotherapy, Non-elective Radiotherapy

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AOUPoliclinicoModenaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open: non elective irradiation

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

rate of severe sub-acute or late toxicity
assessment of toxicity according to CTCAE v5.0 scale
Cause-specific mortality rates
Patients who died from cancer/total amount
overall survival
defined as the time from the date of randomization to the date of death for any cause
progression free survival
per modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
G8 role
correlation between G8 pre-screening evaluation and toxicity

Full Information

First Posted
March 5, 2021
Last Updated
April 1, 2021
Sponsor
Azienda Ospedaliero Universitaria Policlinico Modena
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1. Study Identification

Unique Protocol Identification Number
NCT04832555
Brief Title
Non Elective Vulnerable Elderly Radiotherapy
Acronym
NEVER
Official Title
Non Elective Vulnerable Elderly Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero Universitaria Policlinico Modena

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Head and Neck
Keywords
Elderly, Vulnerable, Radiotherapy, Non-elective Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open: non elective irradiation
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Non elective radiotherapy
Intervention Description
Simultaneous integrated boost on CTV volumes, delineated as per guidelines, with the exception of intermediate-low risk, where the CTVs are experimental.
Primary Outcome Measure Information:
Title
Loco-regional control
Description
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.
Time Frame
24 months after the start of treatment
Secondary Outcome Measure Information:
Title
rate of severe sub-acute or late toxicity
Description
assessment of toxicity according to CTCAE v5.0 scale
Time Frame
at 6 and 12 months after the completion of radiotherapy
Title
Cause-specific mortality rates
Description
Patients who died from cancer/total amount
Time Frame
within 3 months after start of treatment
Title
overall survival
Description
defined as the time from the date of randomization to the date of death for any cause
Time Frame
5 years
Title
progression free survival
Description
per modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
Time Frame
12 and 24 months
Title
G8 role
Description
correlation between G8 pre-screening evaluation and toxicity
Time Frame
6 and 12 months
Other Pre-specified Outcome Measures:
Title
radiomics
Description
evaluation of radiomics features in study population: using an automated high-throughput extraction of large amounts of quantitative features
Time Frame
through study completion, an average of 5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pasquale Mighali, MD
Phone
+39 0594225868
Email
pasqualemighali@aou.mo.it
First Name & Middle Initial & Last Name or Official Title & Degree
Elisa D'Angelo, MD
Phone
+39 3934317599
Email
dangelo.elisa@aou.mo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa D'Angelo
Organizational Affiliation
Azienda Ospedaliero Universitaria Policlinico Modena
Official's Role
Study Chair
Facility Information:
Facility Name
AOUPoliclinicoModena
City
Modena
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pasquale Mighali
Phone
+39 0594225868
Email
pasquale.mighali@aou.mo.it

12. IPD Sharing Statement

Learn more about this trial

Non Elective Vulnerable Elderly Radiotherapy

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