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)
2026年8月20日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
122
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Hélène LASOLLE, PU-PH, MD
- 电话号码：+33 4 27 85 66 66
- 邮箱：helene.lasolle@chu-lyon.fr
研究联系人备份
- 姓名：Cloé JEZEQUEL
- 电话号码：+33 4 72 35 69 12
- 邮箱：cloe.jezequel@chu-lyon.fr
学习地点
-
-
-
Bron、法国、69500
- Fédération d'endocrinologie, Hôpital cardiologique - Groupement Hospitalier Est - Hospices Civils de Lyon
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接触：
- Hélène LASOLLE, PU-PH, MD
- 电话号码：+33 4 27 85 66 66
- 邮箱：helene.lasolle@chu-lyon.fr
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接触：
- Cloé JEZEQUEL
- 电话号码：+33 4 72 35 69 12
- 邮箱：cloe.jezequel@chu-lyon.fr
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首席研究员：
- Hélène LASOLLE, PU-PH, MD
-
Paris、法国、75010
- Service ORL - Hôpital Lariboisière - AP-HP
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接触：
- Philippe HERMAN, PU-PH, MD
- 电话号码：+33 1 49 95 80 64
- 邮箱：philippe.herman099@gmail.com
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首席研究员：
- Philippe HERMAN, PU-PH, MD
-
Paris、法国、75013
- Médecine Nucléaire - Hôpital Pitié-Salpêtrière - AP-HP
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接触：
- Charlotte LUSSEY, PU-PH, MD
- 电话号码：+33 1 42 17 64 94
- 邮箱：charlotte.lussey@aphp.fr
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首席研究员：
- Charlotte LUSSEY, PU-PH, MD
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Paris、法国、75014
- Service d'Endocrinologie - Hôpital Cochin
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首席研究员：
- Rossella LIBE, MD
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接触：
- Rossella LIBE, MD
- 电话号码：+33 1 58 41 19 19
- 邮箱：rossella.libe@aphp.fr
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Paris、法国、75015
- Service Endocrinologie et métabolismes - Hôpital Européen Georges Pompidou - AP-HP
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接触：
- Julien RIANCHO, MD
- 电话号码：+33 1 56 09 57 00
- 邮箱：julien.riancho@aphp.fr
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首席研究员：
- Julien RIANCHO, MD
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Pessac、法国、36604
- Service d'endocrinologie, diabétologie et nutrition - Hôpital Haut-Lévêque - CHU de Bordeaux
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首席研究员：
- Magalie HAISSAGUERRE, MD
-
接触：
- Magalie HAISSAGUERRE, MD
- 电话号码：+33 5 57 65 60 78
- 邮箱：magalie.haissaguerre@chu-bordeaux.fr
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Saint-Herblain、法国、44800
- Service Endocrinologie Diabétologie Nutrition - Hôpital Nord Laennec - CHU de Nantes
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首席研究员：
- Delphine DRUI, MD
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接触：
- Delphine DRUI, MD
- 电话号码：+33 2 40 08 33 33
- 邮箱：delphine.drui@chu-nantes.fr
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Strasbourg、法国、67091
- Endocrinologie, diabète et nutrition - Hôpital de Hautepierre - CHRU de Strasbourg
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首席研究员：
- Philippe BALTZINGER, MD
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接触：
- Philippe BALTZINGER, MD
- 电话号码：+33 3 88 12 76 00
- 邮箱：philippe.baltzinger@chru-strasbourg.fr
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
|
有源比较器：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.
|
Patients may be treated with surgery to remove the paraganglioma within 6 months after randomization.
Patients may be treated with radiation within 6 months after randomization.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to functional outcome deterioration
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evolution of the functional outcomes between the groups
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：At 5 years
|
Characterization of spontaneous tumor evolution in patients with active FU
|
At 5 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Hélène LASOLLE, PU-PH, MD、Hospices Civils de Lyon
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月10日
初级完成 (估计的)
2034年10月10日
研究完成 (估计的)
2034年10月10日
研究注册日期
首次提交
2026年8月4日
首先提交符合 QC 标准的
2026年8月20日
首次发布 (实际的)
2026年8月25日
研究记录更新
最后更新发布 (实际的)
2026年8月25日
上次提交的符合 QC 标准的更新
2026年8月20日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.