ParagangliomasPRONO-PARAG-NNCT07784595
Comparison of an Initial Active Follow-up and Therapeutic Care on Functional Outcome and Quality of Life in Patients With Head and Neck Paragangliomas
A study testing Active follow-up, Surgery and Radiation in people with Paragangliomas, run by Hospices Civils de Lyon at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paragangliomas
- What is being tested?
- Active follow-up, Surgery and Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 8 sitesFrance
- Study dates
- 10 Oct 2026to 10 Oct 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 16Show fewer
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites
Fédération d'endocrinologie, Hôpital cardiologique - Groupement Hospitalier Est - Hospices Civils de Lyon
Bron, 69500
Hélène LASOLLE, PU-PH, MD, +33 4 27 85 66 66, helene.lasolle@chu-lyon.fr
Cloé JEZEQUEL, +33 4 72 35 69 12, cloe.jezequel@chu-lyon.fr
Service ORL - Hôpital Lariboisière - AP-HP
Paris, 75010
Philippe HERMAN, PU-PH, MD, +33 1 49 95 80 64, philippe.herman099@gmail.com
Philippe HERMAN, PU-PH, MD
Médecine Nucléaire - Hôpital Pitié-Salpêtrière - AP-HP
Paris, 75013
Charlotte LUSSEY, PU-PH, MD, +33 1 42 17 64 94, charlotte.lussey@aphp.fr
Charlotte LUSSEY, PU-PH, MD
Service d'Endocrinologie - Hôpital Cochin
Paris, 75014
Rossella LIBE, MD, +33 1 58 41 19 19, rossella.libe@aphp.fr
Rossella LIBE, MD
Service Endocrinologie et métabolismes - Hôpital Européen Georges Pompidou - AP-HP
Paris, 75015
Julien RIANCHO, MD, +33 1 56 09 57 00, julien.riancho@aphp.fr
Julien RIANCHO, MD
Service d'endocrinologie, diabétologie et nutrition - Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, 36604
Magalie HAISSAGUERRE, MD, +33 5 57 65 60 78, magalie.haissaguerre@chu-bordeaux.fr
Magalie HAISSAGUERRE, MD
Service Endocrinologie Diabétologie Nutrition - Hôpital Nord Laennec - CHU de Nantes
Saint-Herblain, 44800
Delphine DRUI, MD, +33 2 40 08 33 33, delphine.drui@chu-nantes.fr
Delphine DRUI, MD
Endocrinologie, diabète et nutrition - Hôpital de Hautepierre - CHRU de Strasbourg
Strasbourg, 67091
Philippe BALTZINGER, MD, +33 3 88 12 76 00, philippe.baltzinger@chru-strasbourg.fr
Philippe BALTZINGER, MD
About this study
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
- Being tested
- Active follow-up, Surgery, Radiation
- Keywords
- Head and neck paraganglioma, Surgery, Radiation therapy, Cranial nerve palsy, Quality of life
- Medical subject headings
- Paraganglioma, Cranial Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active follow-upOther
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.
SurgeryProcedure or surgery
Patients may be treated with surgery to remove the paraganglioma within 6 months after randomization.
RadiationRadiation
Patients may be treated with radiation within 6 months after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Active follow-up | Experimental | Not described Receives: 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. Receives: Procedure: Surgery; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 5 years maximum
Secondary outcomes (13)
Evolution of the functional outcomes between the groups
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.
Measured: Baseline, 1 year and 5 years
Evolution of the functional outcomes between the groups
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.
Measured: Baseline, 1 year and 5 years
Quality of life (QoL)
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.
Measured: Baseline, 1 year and 5 years
Anxiety
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.
Measured: Baseline, 1 year and 5 years
Factors associated with a significant quality of life
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.
Measured: Baseline, 1 year, 5 years
Factors associated with functional outcomes
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.
Measured: Baseline, 1 year, 5 years
Factors associated with anxiety deterioration
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.
Measured: Baseline, 1 year, 5 years
Switch proportion, reason and time to therapeutic intervention
Proportion of patients in the active FU group needing later therapeutic intervention, the reason and the time to therapeutic intervention
Measured: From baseline to study end
Progression/recurrence rate
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.
Measured: From baseline to study end
Surgery complication rate
Proportion of all operated patients with complications post-surgery (Clavien-Dindo classification).
Measured: At 1 year and 5 years
Radiation therapy complication rate
Proportion of all irradiated patients with complications post irradiation (CTCAE V5.0)
Measured: At 1 year and 5 years
Disease progression
Characterization of spontaneous tumor evolution in patients with active FU
Measured: At 1 year and 5 years
Proportion of distant metastasis
Characterization of spontaneous tumor evolution in patients with active FU
Measured: At 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2034 (estimated)
- Study completion10 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParagangliomasStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène LASOLLE, PU-PH, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784595
- Sponsor's protocol ID
- 69HCL24_0915
- Other IDs
- 2025-A02947-42
- Acronym
- PRONO-PARAG-N
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an Initial Active Follow-up and Therapeutic Care on Functional Outcome and Quality of Life in Patients With Head and Neck Paragangliomas
- ClinicalTrials.gov ID
- NCT07784595
- Acronym / sponsor ID
- PRONO-PARAG-N / 69HCL24_0915
- Conditions
- Paragangliomas
- Keywords
- Head and neck paraganglioma, Surgery, Radiation therapy, Cranial nerve palsy, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2034 (estimated)
- Study completion
- 10 Oct 2034 (estimated)
- First posted
- 25 Aug 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active follow-up | Experimental | Other: Active follow-up |
| Treatment | Active comparator | Procedure: Surgery, Radiation: RadiationPatients will be treated by surgery or radiation. The choice between these 2 options is left to the discretion of the investigator and the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (16 listed)
- 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,
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 |
|---|---|---|
| Active follow-upPatients 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. | Other | Active follow-up |
| SurgeryPatients may be treated with surgery to remove the paraganglioma within 6 months after randomization. | Procedure or surgery | Treatment |
| RadiationPatients may be treated with radiation within 6 months after randomization. | Radiation | Treatment |
Primary outcome
Time to functional outcome deterioration
Time frame: 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.
13 secondary outcomes
Evolution of the functional outcomes between the groups
Time frame: Baseline, 1 year and 5 years
Evolution of the functional outcomes between the groups
Time frame: Baseline, 1 year and 5 years
Quality of life (QoL)
Time frame: Baseline, 1 year and 5 years
Anxiety
Time frame: Baseline, 1 year and 5 years
Factors associated with a significant quality of life
Time frame: Baseline, 1 year, 5 years
Factors associated with functional outcomes
Time frame: Baseline, 1 year, 5 years
Factors associated with anxiety deterioration
Time frame: Baseline, 1 year, 5 years
Switch proportion, reason and time to therapeutic intervention
Time frame: From baseline to study end
Progression/recurrence rate
Time frame: From baseline to study end
Surgery complication rate
Time frame: At 1 year and 5 years
Radiation therapy complication rate
Time frame: At 1 year and 5 years
Disease progression
Time frame: At 1 year and 5 years
Proportion of distant metastasis
Time frame: At 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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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.
Hélène LASOLLE, PU-PH, MD principal investigator
Hospices Civils de Lyon
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active follow-up, Surgery and Radiation in people with Paragangliomas, run by Hospices Civils de Lyon at 8 sites in France.
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 16 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: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hélène LASOLLE, PU-PH, MD (+33 4 27 85 66 66, helene.lasolle@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to functional outcome deterioration (time frame: From baseline to 5 years maximum). 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 25 Aug 2026.