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)
2026년 8월 20일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
122
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Hélène LASOLLE, PU-PH, MD
- 전화번호: +33 4 27 85 66 66
- 이메일: helene.lasolle@chu-lyon.fr
연구 연락처 백업
- 이름: Cloé JEZEQUEL
- 전화번호: +33 4 72 35 69 12
- 이메일: cloe.jezequel@chu-lyon.fr
연구 장소
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Bron, 프랑스, 69500
- Fédération d'endocrinologie, Hôpital cardiologique - Groupement Hospitalier Est - Hospices Civils de Lyon
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연락하다:
- Hélène LASOLLE, PU-PH, MD
- 전화번호: +33 4 27 85 66 66
- 이메일: helene.lasolle@chu-lyon.fr
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연락하다:
- Cloé JEZEQUEL
- 전화번호: +33 4 72 35 69 12
- 이메일: cloe.jezequel@chu-lyon.fr
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수석 연구원:
- Hélène LASOLLE, PU-PH, MD
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Paris, 프랑스, 75010
- Service ORL - Hôpital Lariboisière - AP-HP
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연락하다:
- Philippe HERMAN, PU-PH, MD
- 전화번호: +33 1 49 95 80 64
- 이메일: philippe.herman099@gmail.com
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수석 연구원:
- Philippe HERMAN, PU-PH, MD
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Paris, 프랑스, 75013
- Médecine Nucléaire - Hôpital Pitié-Salpêtrière - AP-HP
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연락하다:
- Charlotte LUSSEY, PU-PH, MD
- 전화번호: +33 1 42 17 64 94
- 이메일: charlotte.lussey@aphp.fr
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수석 연구원:
- Charlotte LUSSEY, PU-PH, MD
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Paris, 프랑스, 75014
- Service d'Endocrinologie - Hôpital Cochin
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수석 연구원:
- Rossella LIBE, MD
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연락하다:
- Rossella LIBE, MD
- 전화번호: +33 1 58 41 19 19
- 이메일: rossella.libe@aphp.fr
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Paris, 프랑스, 75015
- Service Endocrinologie et métabolismes - Hôpital Européen Georges Pompidou - AP-HP
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연락하다:
- Julien RIANCHO, MD
- 전화번호: +33 1 56 09 57 00
- 이메일: julien.riancho@aphp.fr
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수석 연구원:
- Julien RIANCHO, MD
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Pessac, 프랑스, 36604
- Service d'endocrinologie, diabétologie et nutrition - Hôpital Haut-Lévêque - CHU de Bordeaux
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수석 연구원:
- Magalie HAISSAGUERRE, MD
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연락하다:
- Magalie HAISSAGUERRE, MD
- 전화번호: +33 5 57 65 60 78
- 이메일: magalie.haissaguerre@chu-bordeaux.fr
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Saint-Herblain, 프랑스, 44800
- Service Endocrinologie Diabétologie Nutrition - Hôpital Nord Laennec - CHU de Nantes
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수석 연구원:
- Delphine DRUI, MD
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연락하다:
- Delphine DRUI, MD
- 전화번호: +33 2 40 08 33 33
- 이메일: delphine.drui@chu-nantes.fr
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Strasbourg, 프랑스, 67091
- Endocrinologie, diabète et nutrition - Hôpital de Hautepierre - CHRU de Strasbourg
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수석 연구원:
- Philippe BALTZINGER, MD
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연락하다:
- Philippe BALTZINGER, MD
- 전화번호: +33 3 88 12 76 00
- 이메일: philippe.baltzinger@chru-strasbourg.fr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Active follow-up
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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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활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to functional outcome deterioration
기간: 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.
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From baseline to 5 years maximum
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Evolution of the functional outcomes between the groups
기간: 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.
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Baseline, 1 year and 5 years
|
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Evolution of the functional outcomes between the groups
기간: Baseline, 1 year and 5 years
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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.
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Baseline, 1 year and 5 years
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Quality of life (QoL)
기간: Baseline, 1 year and 5 years
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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.
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Baseline, 1 year and 5 years
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Anxiety
기간: 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.
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Baseline, 1 year and 5 years
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Factors associated with a significant quality of life
기간: 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
기간: 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
|
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Factors associated with anxiety deterioration
기간: 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.
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Baseline, 1 year, 5 years
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Switch proportion, reason and time to therapeutic intervention
기간: From baseline to study end
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Proportion of patients in the active FU group needing later therapeutic intervention, the reason and the time to therapeutic intervention
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From baseline to study end
|
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Progression/recurrence rate
기간: 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.
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From baseline to study end
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Surgery complication rate
기간: At 1 year and 5 years
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Proportion of all operated patients with complications post-surgery (Clavien-Dindo classification).
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At 1 year and 5 years
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Radiation therapy complication rate
기간: At 1 year and 5 years
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Proportion of all irradiated patients with complications post irradiation (CTCAE V5.0)
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At 1 year and 5 years
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Disease progression
기간: At 1 year and 5 years
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Characterization of spontaneous tumor evolution in patients with active FU
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At 1 year and 5 years
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Proportion of distant metastasis
기간: At 5 years
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Characterization of spontaneous tumor evolution in patients with active FU
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At 5 years
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Hélène LASOLLE, PU-PH, MD, Hospices Civils de Lyon
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 10월 10일
기본 완료 (추정된)
기본 완료
2034년 10월 10일
연구 완료 (추정된)
연구 완료
2034년 10월 10일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 4일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 20일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 25일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 20일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 69HCL24_0915
- 2025-A02947-42 (레지스트리 식별자: ID-RCB)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .