Squamous Cell Carcinoma of Head and NeckNEVERNCT04832555
Non Elective Vulnerable Elderly Radiotherapy
A study testing Non elective radiotherapy in people with Squamous Cell Carcinoma of Head and Neck, run by Azienda Ospedaliero Universitaria Policlinico Modena at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Non elective radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2021to Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOUPoliclinicoModena
Modena
Pasquale Mighali, +39 0594225868, pasquale.mighali@aou.mo.it
About this study
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.
Read the 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.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- Non elective radiotherapy
- Keywords
- Elderly, Vulnerable, Radiotherapy, Non-elective Radiotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non elective radiotherapyRadiation
Simultaneous integrated boost on CTV volumes, delineated as per guidelines, with the exception of intermediate-low risk, where the CTVs are experimental.
| Study group | Role | What they receive |
|---|---|---|
| Open: non elective irradiation | Experimental | 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 Receives: Radiation: Non elective radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months after the start of treatment
Secondary outcomes (5)
rate of severe sub-acute or late toxicity
assessment of toxicity according to CTCAE v5.0 scale
Measured: at 6 and 12 months after the completion of radiotherapy
Cause-specific mortality rates
Patients who died from cancer/total amount
Measured: within 3 months after start of treatment
overall survival
defined as the time from the date of randomization to the date of death for any cause
Measured: 5 years
progression free survival
per modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
Measured: 12 and 24 months
G8 role
correlation between G8 pre-screening evaluation and toxicity
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start20 Feb 2021
- Primary completionJul 2023 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Policlinico Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa D'angelo, Azienda Ospedaliero Universitaria Policlinico Modena
- Investigators
- Elisa D'Angelo, Study chair, Azienda Ospedaliero Universitaria Policlinico Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832555
- Sponsor's protocol ID
- NEVER
- Acronym
- NEVER
- Status last verified
- Apr 2021
- First submitted
- 5 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Elective Vulnerable Elderly Radiotherapy
- ClinicalTrials.gov ID
- NCT04832555
- Acronym / sponsor ID
- NEVER / NEVER
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- Elderly, Vulnerable, Radiotherapy, Non-elective Radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Policlinico ModenaUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open: non elective irradiation | Experimental | Radiation: Non elective radiotherapyPatients 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Age less than 70 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non elective radiotherapySimultaneous integrated boost on CTV volumes, delineated as per guidelines, with the exception of intermediate-low risk, where the CTVs are experimental. | Radiation | Open: non elective irradiation |
Primary outcome
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.
5 secondary outcomes
rate of severe sub-acute or late toxicity
Time frame: at 6 and 12 months after the completion of radiotherapy
Cause-specific mortality rates
Time frame: within 3 months after start of treatment
overall survival
Time frame: 5 years
progression free survival
Time frame: 12 and 24 months
G8 role
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa D'Angelo study chair
Azienda Ospedaliero Universitaria Policlinico Modena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non elective radiotherapy in people with Squamous Cell Carcinoma of Head and Neck, run by Azienda Ospedaliero Universitaria Policlinico Modena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pasquale Mighali, MD (+39 0594225868, pasqualemighali@aou.mo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loco-regional control (time frame: 24 months after the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.