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

NCT07784595 | Not Yet Recruiting

• 2 other identifiers: 69HCL24_09152025-A02947-42
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Paragangliomas

Keywords

Head and neck paraganglioma; Surgery; Radiation therapy; Cranial nerve palsy; Quality of life

Outcome Measures

Primary Outcomes (1)

• Time to functional outcome deterioration

  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

Secondary Outcomes (13)

• Evolution of the functional outcomes between the groups

  Baseline, 1 year and 5 years

• Evolution of the functional outcomes between the groups

  Baseline, 1 year and 5 years

• Quality of life (QoL)

  Baseline, 1 year and 5 years

• Anxiety

  Baseline, 1 year and 5 years

• Factors associated with a significant quality of life

  Baseline, 1 year, 5 years

Study Arms (2)

Active follow-up

EXPERIMENTAL

Other: Active follow-up

Treatment

ACTIVE COMPARATOR

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.

Procedure: Surgery; Radiation: Radiation

Interventions

Active follow-up OTHER

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.

Active follow-up

Surgery PROCEDURE

Patients may be treated with surgery to remove the paraganglioma within 6 months after randomization.

Treatment

Radiation RADIATION

Patients may be treated with radiation within 6 months after randomization.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (8)

Fédération d'endocrinologie, Hôpital cardiologique - Groupement Hospitalier Est - Hospices Civils de Lyon

Bron, 69500, France

Location

Service ORL - Hôpital Lariboisière - AP-HP

Paris, 75010, France

Location

Médecine Nucléaire - Hôpital Pitié-Salpêtrière - AP-HP

Paris, 75013, France

Location

Service d'Endocrinologie - Hôpital Cochin

Paris, 75014, France

Location

Service Endocrinologie et métabolismes - Hôpital Européen Georges Pompidou - AP-HP

Paris, 75015, France

Location

Service d'endocrinologie, diabétologie et nutrition - Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, 36604, France

Location

Service Endocrinologie Diabétologie Nutrition - Hôpital Nord Laennec - CHU de Nantes

Saint-Herblain, 44800, France

Location

Endocrinologie, diabète et nutrition - Hôpital de Hautepierre - CHRU de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Paraganglioma; Cranial Nerve Diseases

Interventions

Surgical Procedures, Operative; Radiation

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Hélène LASOLLE, PU-PH, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hélène LASOLLE, PU-PH, MD

CONTACT

+33 4 27 85 66 66; helene.lasolle@chu-lyon.fr

Cloé JEZEQUEL

CONTACT

+33 4 72 35 69 12; cloe.jezequel@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): October 10, 2026
• Primary Completion (Estimated): October 10, 2034
• Study Completion (Estimated): October 10, 2034
• Last Updated: August 25, 2026

Record last verified: 2026-08

Locations

FR (8)