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Comparison of an Initial Active Follow-up and Therapeutic Care on Functional Outcome and Quality of Life in Patients With Head and Neck Paragangliomas (PRONO-PARAG-N)

20 agosto 2026 aggiornato da: Hospices Civils de Lyon
Head and neck paragangliomas (HNPGs) are predominantly non-secreting, benign and slow-growing tumors. Although most patients remain asymptomatic, up to 30% develop symptoms related to local tumor growth and fewer than 5-10% develop metastatic disease. Surgery has long been considered the standard treatment, while radiotherapy and active surveillance represent alternative management strategies. Treatment-related morbidity and impaired quality of life have been reported in patients with HNPGs; however, the impact of immediate intervention compared with an initial active surveillance strategy has not been prospectively evaluated. This multicenter randomized controlled trial aims to compare active surveillance with immediate intervention in patients with newly diagnosed carotid or vagal paragangliomas. The study hypothesis is that an initial active surveillance strategy increases the time before functional outcome deterioration, particularly ENT-related symptoms, while not resulting in a higher complication rate when treatment is subsequently performed. Eligible patients will undergo baseline assessment including a specialized ENT examination to evaluate cranial nerve function and cervical MRI (or contrast-enhanced CT when MRI is contraindicated) to confirm tumor location, size, and the absence of lymphadenopathy or atypical imaging features. After providing written informed consent, participants will be centrally randomized in a 1:1 ratio, stratified by study center and tumor location, to either active surveillance or immediate intervention. Patients assigned to active surveillance will undergo regular clinical and radiological follow-up, with treatment initiated only if disease progression or symptom development warrants intervention. Patients assigned to immediate intervention will receive surgery or radiotherapy according to multidisciplinary team recommendations and local practice, within six months after randomization. Patients who decline participation in the randomized trial, as well as those who are not eligible for randomization, may be offered participation in a parallel observational study collecting clinical, imaging, treatment and outcome data according to routine practice. Patient quality of life will also be assessed throughout the study (experimental and observational) using validated questionnaires.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

122

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Francia
      • Bron, Francia, 69500
        • Fédération d'endocrinologie, Hôpital cardiologique - Groupement Hospitalier Est - Hospices Civils de Lyon
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Hélène LASOLLE, PU-PH, MD
      • Paris, Francia, 75010
        • Service ORL - Hôpital Lariboisière - AP-HP
        • Contatto:
        • Investigatore principale:
          • Philippe HERMAN, PU-PH, MD
      • Paris, Francia, 75013
        • Médecine Nucléaire - Hôpital Pitié-Salpêtrière - AP-HP
        • Contatto:
        • Investigatore principale:
          • Charlotte LUSSEY, PU-PH, MD
      • Paris, Francia, 75014
        • Service d'Endocrinologie - Hôpital Cochin
        • Investigatore principale:
          • Rossella LIBE, MD
        • Contatto:
      • Paris, Francia, 75015
        • Service Endocrinologie et métabolismes - Hôpital Européen Georges Pompidou - AP-HP
        • Contatto:
        • Investigatore principale:
          • Julien RIANCHO, MD
      • Pessac, Francia, 36604
        • Service d'endocrinologie, diabétologie et nutrition - Hôpital Haut-Lévêque - CHU de Bordeaux
        • Investigatore principale:
          • Magalie HAISSAGUERRE, MD
        • Contatto:
      • Saint-Herblain, Francia, 44800
        • Service Endocrinologie Diabétologie Nutrition - Hôpital Nord Laennec - CHU de Nantes
        • Investigatore principale:
          • Delphine DRUI, MD
        • Contatto:
      • Strasbourg, Francia, 67091
        • Endocrinologie, diabète et nutrition - Hôpital de Hautepierre - CHRU de Strasbourg
        • Investigatore principale:
          • Philippe BALTZINGER, MD
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Patients ≥ 18 years-old,
  • Diagnosis of carotid or vagal HNPG with a largest diameter more than 10 mm
  • Diagnosis confirmed by imaging reading (MRI of CT scan) from less than 6 months,
  • Study eligibility validated in multidisciplinary discussion,
  • Patient followed in the reference center,
  • Preliminary written informed consent before any study-specific intervention

Exclusion Criteria:

  • Patient with initial nerve palsy due to the evaluated HNPG,
  • Patient with non-typical presentation suggestive of aggressiveness (tumor pain, atypical imaging, suspicious lymphadenopathy),
  • Malignant HNPG identified by extra cervical lesion on metabolic imaging,
  • More than one HNPG at inclusion
  • Secreting HNPG defined as plasma or urine metanephrine or normetanephrine more than 2 times ULN,
  • Patient already treated with cervical radiotherapy,
  • Patient already treated with systemic therapy for another pheochromocytoma or paraganglioma,
  • Patient with another evolutive disease or other condition resulting on a life expectancy of less than 5 years at the investigator's discretion,
  • Patient unable or unwilling to be treated at the study center
  • Patients currently enrolled in another interventional study including investigational medicinal products or device,
  • Female patients who are pregnant, lactating or women of child-bearing potential without highly effective methods of contraception
  • Persons deprived of their liberty by a judicial or administrative decision
  • Persons under psychiatric care
  • Persons admitted to a health or social institution for purposes other than research
  • Adults subject to a legal protection measure (guardianship, curatorship)
  • Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Active follow-up
Altro: Active follow-up
Patients will not receive any treatment, they will undergo annual follow-up assessments according to the standard of care. Upon disease progression, patients will be allowed to switch to the treatment group.
Comparatore attivo: Treatment
Patients will be treated by surgery or radiation. The choice between these 2 options is left to the discretion of the investigator and the patient.
Procedura: Surgery
Patients may be treated with surgery to remove the paraganglioma within 6 months after randomization.
Radiazione: Radiation
Patients may be treated with radiation within 6 months after randomization.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to functional outcome deterioration
Lasso di tempo: From baseline to 5 years maximum
Time to functional outcome deterioration is defined as the delay between inclusion and functional outcome deterioration. Patients without functional deterioration are censored at their last functional assessment. Functional outcome deterioration is defined as a decrease in at least 12 points (or 8.6%) of the FACT H&N score since inclusion. The FACT-H&N score ranges from 0 to 148. The higher the score, the better the quality of life.
From baseline to 5 years maximum

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Evolution of the functional outcomes between the groups
Lasso di tempo: Baseline, 1 year and 5 years
Functional outcomes are defined by the overall score of the FACT H&N in both groups. The FACT-H&N score ranges from 0 to 148. The higher the score, the better the quality of life.
Baseline, 1 year and 5 years
Evolution of the functional outcomes between the groups
Lasso di tempo: Baseline, 1 year and 5 years
Functional outcomes are defined by the overall score of the EORTC QLQ-HN43 in both groups. The scores of the EORTC QLQ-HN43 module are standardized on a scale from 0 to 100. For all symptom scales, a higher score reflects greater symptom burden and poorer quality of life.
Baseline, 1 year and 5 years
Quality of life (QoL)
Lasso di tempo: Baseline, 1 year and 5 years
Change on QoL in both groups assessed by the global health status score of the EORTC QLQ-C30. The scores of the EORTC QLQ-C30 questionnaire are standardized on a scale from 0 to 100. A higher score reflects a better level of functioning and a better quality of life.
Baseline, 1 year and 5 years
Anxiety
Lasso di tempo: Baseline, 1 year and 5 years
Change on the anxiety evaluation in both groups assessed by HAD scale. The higher the score, the greater the severity of anxiety or depressive symptoms. The total score ranges from 0 to 42.
Baseline, 1 year and 5 years
Factors associated with a significant quality of life
Lasso di tempo: Baseline, 1 year, 5 years
Variation of at least 10% of the global health status score of the EORTC QLQ-C30. The scores of the EORTC QLQ-C30 questionnaire are standardized on a scale from 0 to 100. A higher score reflects a better level of functioning and a better quality of life.
Baseline, 1 year, 5 years
Factors associated with functional outcomes
Lasso di tempo: Baseline, 1 year, 5 years
Variation of at least 10% of the one of the scales of the QLQ-HN43. The scores of the EORTC QLQ-HN43 module are standardized on a scale from 0 to 100. For all symptom scales, a higher score reflects greater symptom burden and poorer quality of life.
Baseline, 1 year, 5 years
Factors associated with anxiety deterioration
Lasso di tempo: Baseline, 1 year, 5 years
Variation of at least 10% of the anxiety scale of HAD. The Hospital Anxiety and Depression Scale (HADS) consists of two subscales including anxiety. Each subscale ranges from 0 to 21, with higher scores reflecting more severe symptomatology.
Baseline, 1 year, 5 years
Switch proportion, reason and time to therapeutic intervention
Lasso di tempo: From baseline to study end
Proportion of patients in the active FU group needing later therapeutic intervention, the reason and the time to therapeutic intervention
From baseline to study end
Progression/recurrence rate
Lasso di tempo: From baseline to study end
Time to progression/recurrence defined as the delay between inclusion and tumor progression in all groups (20% increase in one diameter increase according to RECIST 1.1 criteria, spread metastasis or tumor appearance after total removal). Patients without progression/recurrence will be censored at the last imaging assessment. At least, one assessment will be conducted at 5 years.
From baseline to study end
Surgery complication rate
Lasso di tempo: At 1 year and 5 years
Proportion of all operated patients with complications post-surgery (Clavien-Dindo classification).
At 1 year and 5 years
Radiation therapy complication rate
Lasso di tempo: At 1 year and 5 years
Proportion of all irradiated patients with complications post irradiation (CTCAE V5.0)
At 1 year and 5 years
Disease progression
Lasso di tempo: At 1 year and 5 years
Characterization of spontaneous tumor evolution in patients with active FU
At 1 year and 5 years
Proportion of distant metastasis
Lasso di tempo: At 5 years
Characterization of spontaneous tumor evolution in patients with active FU
At 5 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hospices Civils de Lyon

Investigatori

  • Investigatore principale: Hélène LASOLLE, PU-PH, MD, Hospices Civils de Lyon

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 ottobre 2026

Completamento primario (Stimato)

10 ottobre 2034

Completamento dello studio (Stimato)

10 ottobre 2034

Date di iscrizione allo studio

Primo inviato

4 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 agosto 2026

Primo Inserito (Effettivo)

25 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 69HCL24_0915
  • 2025-A02947-42 (Identificatore di registro: ID-RCB)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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