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.
調査の概要
研究の種類
介入
入学 (推定)
122
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Hélène LASOLLE, PU-PH, MD
- 電話番号：+33 4 27 85 66 66
- メール：helene.lasolle@chu-lyon.fr
研究連絡先のバックアップ
- 名前：Cloé JEZEQUEL
- 電話番号：+33 4 72 35 69 12
- メール：cloe.jezequel@chu-lyon.fr
研究場所
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-
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Bron、フランス、69500
- Fédération d'endocrinologie, Hôpital cardiologique - Groupement Hospitalier Est - Hospices Civils de Lyon
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コンタクト：
- Hélène LASOLLE, PU-PH, MD
- 電話番号：+33 4 27 85 66 66
- メール：helene.lasolle@chu-lyon.fr
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コンタクト：
- Cloé JEZEQUEL
- 電話番号：+33 4 72 35 69 12
- メール：cloe.jezequel@chu-lyon.fr
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主任研究者：
- Hélène LASOLLE, PU-PH, MD
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Paris、フランス、75010
- Service ORL - Hôpital Lariboisière - AP-HP
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コンタクト：
- Philippe HERMAN, PU-PH, MD
- 電話番号：+33 1 49 95 80 64
- メール：philippe.herman099@gmail.com
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主任研究者：
- Philippe HERMAN, PU-PH, MD
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Paris、フランス、75013
- Médecine Nucléaire - Hôpital Pitié-Salpêtrière - AP-HP
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コンタクト：
- Charlotte LUSSEY, PU-PH, MD
- 電話番号：+33 1 42 17 64 94
- メール：charlotte.lussey@aphp.fr
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主任研究者：
- Charlotte LUSSEY, PU-PH, MD
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Paris、フランス、75014
- Service d'Endocrinologie - Hôpital Cochin
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主任研究者：
- Rossella LIBE, MD
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コンタクト：
- Rossella LIBE, MD
- 電話番号：+33 1 58 41 19 19
- メール：rossella.libe@aphp.fr
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Paris、フランス、75015
- Service Endocrinologie et métabolismes - Hôpital Européen Georges Pompidou - AP-HP
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コンタクト：
- Julien RIANCHO, MD
- 電話番号：+33 1 56 09 57 00
- メール：julien.riancho@aphp.fr
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主任研究者：
- Julien RIANCHO, MD
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Pessac、フランス、36604
- Service d'endocrinologie, diabétologie et nutrition - Hôpital Haut-Lévêque - CHU de Bordeaux
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主任研究者：
- Magalie HAISSAGUERRE, MD
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コンタクト：
- Magalie HAISSAGUERRE, MD
- 電話番号：+33 5 57 65 60 78
- メール：magalie.haissaguerre@chu-bordeaux.fr
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Saint-Herblain、フランス、44800
- Service Endocrinologie Diabétologie Nutrition - Hôpital Nord Laennec - CHU de Nantes
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主任研究者：
- Delphine DRUI, MD
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コンタクト：
- Delphine DRUI, MD
- 電話番号：+33 2 40 08 33 33
- メール：delphine.drui@chu-nantes.fr
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Strasbourg、フランス、67091
- Endocrinologie, diabète et nutrition - Hôpital de Hautepierre - CHRU de Strasbourg
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主任研究者：
- Philippe BALTZINGER, MD
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コンタクト：
- Philippe BALTZINGER, MD
- 電話番号：+33 3 88 12 76 00
- メール：philippe.baltzinger@chru-strasbourg.fr
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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アクティブコンパレータ：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.
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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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to functional outcome deterioration
時間枠：From baseline to 5 years maximum
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evolution of the functional outcomes between the groups
時間枠：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
時間枠：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)
時間枠：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
|
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Anxiety
時間枠：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
|
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Factors associated with a significant quality of life
時間枠：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
|
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Factors associated with functional outcomes
時間枠：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
時間枠：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
|
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Switch proportion, reason and time to therapeutic intervention
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：At 1 year and 5 years
|
Characterization of spontaneous tumor evolution in patients with active FU
|
At 1 year and 5 years
|
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Proportion of distant metastasis
時間枠：At 5 years
|
Characterization of spontaneous tumor evolution in patients with active FU
|
At 5 years
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Hélène LASOLLE, PU-PH, MD、Hospices Civils de Lyon
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月10日
一次修了 (推定)
2034年10月10日
研究の完了 (推定)
2034年10月10日
試験登録日
最初に提出
2026年8月4日
QC基準を満たした最初の提出物
2026年8月20日
最初の投稿 (実際)
2026年8月25日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月25日
QC基準を満たした最後の更新が送信されました
2026年8月20日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。