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Non Elective Vulnerable Elderly Radiotherapy (NEVER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04832555
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Information provided by (Responsible Party):
Elisa D'angelo, 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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Head and Neck Radiation: Non elective radiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non Elective Vulnerable Elderly Radiotherapy
Actual Study Start Date : February 20, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Open: non elective irradiation
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
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. rate of severe sub-acute or late toxicity [ Time Frame: at 6 and 12 months after the completion of radiotherapy ]
    assessment of toxicity according to CTCAE v5.0 scale

  2. Cause-specific mortality rates [ Time Frame: within 3 months after start of treatment ]
    Patients who died from cancer/total amount

  3. overall survival [ Time Frame: 5 years ]
    defined as the time from the date of randomization to the date of death for any cause

  4. progression free survival [ Time Frame: 12 and 24 months ]
    per modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1

  5. G8 role [ Time Frame: 6 and 12 months ]
    correlation between G8 pre-screening evaluation and toxicity

Other Outcome Measures:
  1. radiomics [ Time Frame: through study completion, an average of 5 year ]
    evaluation of radiomics features in study population: using an automated high-throughput extraction of large amounts of quantitative features

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04832555

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Contact: Pasquale Mighali, MD +39 0594225868
Contact: Elisa D'Angelo, MD +39 3934317599

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AOUPoliclinicoModena Recruiting
Modena, Italy
Contact: Pasquale Mighali    +39 0594225868   
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Policlinico Modena
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Study Chair: Elisa D'Angelo Azienda Ospedaliero Universitaria Policlinico Modena
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Responsible Party: Elisa D'angelo, Medical Doctor, MD, Azienda Ospedaliero Universitaria Policlinico Modena Identifier: NCT04832555    
Other Study ID Numbers: NEVER
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elisa D'angelo, Azienda Ospedaliero Universitaria Policlinico Modena:
Non-elective Radiotherapy
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Head and Neck Neoplasms
Neoplasms by Site