Impacted Tooth Management and Osteoradionecrosis Risk in NPC
Omission of Prophylactic Impacted Tooth Extraction and Risk of Jaw Osteoradionecrosis in Nasopharyngeal Carcinoma: A Multicenter, Noninferiority, Open-Label, Randomized Controlled Trial
This multicenter, randomized controlled trial is designed to determine whether omitting prophylactic extraction of impacted teeth before radiotherapy leads to an unacceptably higher risk of jaw osteoradionecrosis (JORN) compared with conventional prophylactic extraction in patients with non-metastatic nasopharyngeal carcinoma (NPC). JORN is a condition in which jawbone tissue is damaged and fails to heal properly after radiotherapy.
A total of 536 eligible participants with at least one impacted tooth will be randomly assigned to either omit prophylactic extraction of impacted teeth before radiotherapy or undergo conventional prophylactic extraction before radiotherapy. All participants will receive standard curative-intent intensity-modulated radiotherapy (IMRT), with chemotherapy administered when indicated according to the study protocol.
Participants will be followed for up to 5 years. The primary outcome is the incidence of JORN within 2 years after completion of radiotherapy. Secondary outcomes include longer-term incidence of JORN, overall survival, locoregional relapse-free survival, distant metastasis-free survival, quality of life, and treatment-related toxicities.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Prophylactic extraction of impacted teeth before radiotherapy is performed to reduce the potential risk of dental complications and jaw osteoradionecrosis after treatment. However, whether prophylactic extraction is necessary for impacted teeth without indications for therapeutic extraction remains uncertain.
This study is designed to evaluate whether omission of prophylactic impacted tooth extraction is noninferior to conventional prophylactic extraction with respect to the risk of jaw osteoradionecrosis in patients with non-metastatic nasopharyngeal carcinoma undergoing curative-intent radiotherapy. The study will also assess the long-term clinical outcomes and safety of this tooth-management strategy.
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Li Jiang, MD
- Numer telefonu: +86 15994349883
- E-mail: jiangli@sr.gxmu.edu.cn
Kopia zapasowa kontaktu do badania
- Nazwa: Zhen Meng, MD
- Numer telefonu: +86 15578301825
- E-mail: mengzhen0307@163.com
Lokalizacje studiów
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Guangxi
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Baise City, Guangxi, Chiny, 533000
- Affiliated Hospital of Youjiang Medical University for Nationalities
-
Kontakt:
- Tingzhuang Yi, MD
- Numer telefonu: +86 776-2802090
- E-mail: ytz20070101@163.com
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Beihai, Guangxi, Chiny, 536000
- Beihai People's Hospital
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Kontakt:
- Sihui Liao, MD
- Numer telefonu: +86 779 2023316
- E-mail: 13507799365@136.com
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Guigang, Guangxi, Chiny, 537100
- Guigang People's Hospital
-
Kontakt:
- Yan Wei, MD
- Numer telefonu: +86 15678865869
- E-mail: wyan184@163.com
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Guilin, Guangxi, Chiny, 541001
- The Affiliated Hospital of Guilin Medical University
-
Kontakt:
- Xin Zhang, MD
- Numer telefonu: +86 773 2833086
- E-mail: zhangxin1262008@126.com
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Liuzhou, Guangxi, Chiny, 545006
- Liuzhou People's Hospital
-
Kontakt:
- Jingchang Li, MD
- Numer telefonu: +86 18078259868
- E-mail: 549026160@qq.com
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Liuzhou, Guangxi, Chiny, 545007
- Liuzhou Workers' Hospital
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Kontakt:
- Ying Lu, MD
- Numer telefonu: +86 772 3815405
- E-mail: 1786734840@qq.com
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Nanning, Guangxi, Chiny, 530021
- The First Affiliated Hospital of Guangxi Medical University
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Kontakt:
- Li Jiang, MD
- Numer telefonu: +86 15994349883
- E-mail: jiangli@sr.gxmu.edu.cn
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Nanning, Guangxi, Chiny, 530000
- The People's Hospital of Guangxi Zhuang Autonomous Region
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Kontakt:
- Heming Lu, MD
- Numer telefonu: +860771-5722416
- E-mail: luhming3632@163.com
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Nanning, Guangxi, Chiny, 530199
- Wuming Hospital Affiliated to Guangxi Medical University
-
Kontakt:
- Weiming Zhang, MS
- Numer telefonu: +86 771-6363880
- E-mail: weiming8207@163.com
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Wuzhou, Guangxi, Chiny, 543002
- Wuzhou Red Cross Hospital
-
Kontakt:
- Jianquan Gao, MD
- Numer telefonu: +86 774 3827268
- E-mail: wzhh13878480321@163.com
-
Yulin, Guangxi, Chiny, 537000
- The First People's Hospital of Yulin
-
Kontakt:
- Leifeng Liang, MD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Age 18-75 years, regardless of sex.
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma, including differentiated or undifferentiated subtype (WHO type II or III).
- Newly diagnosed, previously untreated nasopharyngeal carcinoma with stage T1-4N0-3M0 according to the 9th edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system.
- Presence of permanent dentition with at least one impacted third molar.
- Adequate bone marrow function, defined as white blood cell count ≥4.0 × 10⁹/L, platelet count ≥100 × 10⁹/L, and hemoglobin ≥90 g/L.
- Adequate hepatic function, defined as alanine aminotransferase and aspartate aminotransferase ≤2.5 × the upper limit of normal (ULN), and total bilirubin ≤1.5 × ULN.
- Adequate renal function, defined as blood urea nitrogen and serum creatinine ≤1.5 × ULN, or creatinine clearance ≥60 mL/min.
- Coagulation function within normal limits.
- Written informed consent provided, with willingness and ability to comply with study visits, treatment plans, laboratory assessments, and other study procedures.
Exclusion Criteria:
- Histopathological diagnosis other than WHO type II or III nasopharyngeal carcinoma.
- Impacted third molars with recurrent pericoronitis or inflammation due to incomplete eruption.
- Fully erupted third molars with dental caries involving the pulp.
- Impacted third molars with radiographic evidence of periapical or periodontal inflammation.
- Third molars completely impacted within the jawbone.
- History of active malignancy or other malignant tumors diagnosed within the previous 5 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ.
- Previous chemotherapy, surgery (except diagnostic procedures), radiotherapy, or other antitumor treatment for nasopharyngeal carcinoma or cervical lesions.
- Patients receiving palliative treatment.
- Pregnant or breastfeeding women.
- Severe uncontrolled cardiovascular or cerebrovascular diseases.
- Severe hepatic or renal dysfunction.
- Uncontrolled diabetes mellitus.
- Severe osteoporosis, medication-related osteonecrosis/osteomyelitis, or chronic diseases requiring long-term systemic corticosteroid therapy.
- Other severe chronic debilitating diseases that may increase study risk or affect study compliance.
- History of drug abuse or alcohol dependence.
- Uncontrolled psychiatric disorders or inability to provide legally valid informed consent.
- Positive hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA >1,000 copies/mL.
- Active hepatitis C virus infection (positive HCV RNA).
- Human immunodeficiency virus (HIV) infection or diagnosis of acquired immunodeficiency syndrome (AIDS).
- Active tuberculosis within the previous 1 year.
- History of active tuberculosis more than 1 year previously without documented completion of standard anti-tuberculosis treatment.
- Any other medical, psychological, social, or laboratory condition that, in the investigator's judgment, may compromise participant safety, interfere with study procedures, affect protocol compliance, or result in premature withdrawal from the study.
- Refusal or inability to provide written informed consent.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Eksperymentalny: Omission of Prophylactic Extraction Group
Participants assigned to this group will not undergo prophylactic extraction of impacted teeth before radiotherapy.
|
Participants will not undergo prophylactic extraction of eligible impacted teeth before radiotherapy.
|
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Aktywny komparator: Conventional Prophylactic Extraction Group
Participants assigned to this group will undergo conventional prophylactic extraction of impacted teeth before radiotherapy.
|
Participants will undergo prophylactic extraction of eligible impacted teeth before radiotherapy according to the study protocol.
|
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
2-Year Cumulative Incidence of Jaw Osteoradionecrosis
Ramy czasowe: Within 24 months after completion of radiotherapy
|
The cumulative incidence of jaw osteoradionecrosis (JORN) within 24 months after completion of radiotherapy will be estimated and compared between the two treatment groups.
|
Within 24 months after completion of radiotherapy
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
2-Year Overall Survival
Ramy czasowe: 24 months after randomization
|
The 2-year overall survival rate will be estimated as the probability of remaining alive at 24 months after randomization and compared between the two treatment groups.
|
24 months after randomization
|
|
2-Year Event-Free Survival
Ramy czasowe: 24 months after randomization
|
The 2-year event-free survival rate will be estimated as the probability of remaining free from local recurrence, regional recurrence, distant metastasis, or death from any cause at 24 months after randomization and compared between the two treatment groups.
|
24 months after randomization
|
|
2-Year Local Relapse-Free Survival
Ramy czasowe: 24 months after randomization
|
The 2-year local relapse-free survival rate will be estimated as the probability of remaining free from local recurrence or death at 24 months after randomization and compared between the two treatment groups.
|
24 months after randomization
|
|
2-Year Regional Relapse-Free Survival
Ramy czasowe: 24 months after randomization
|
The 2-year regional relapse-free survival rate will be estimated as the probability of remaining free from regional recurrence or death at 24 months after randomization and compared between the two treatment groups.
|
24 months after randomization
|
|
2-Year Distant Metastasis-Free Survival
Ramy czasowe: 24 months after randomization
|
The 2-year distant metastasis-free survival rate will be estimated as the probability of remaining free from distant metastasis or death from any cause at 24 months after randomization and compared between the two treatment groups.
|
24 months after randomization
|
|
Quality of Life Assessed by the EORTC QLQ-C30
Ramy czasowe: Baseline and 3, 6, 12, and 24 months after completion of radiotherapy
|
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
Scores are transformed to a 0-100 scale.
Higher scores on the functional scales and global health status/quality-of-life scale indicate better functioning or quality of life, whereas higher scores on the symptom scales indicate greater symptom burden.
|
Baseline and 3, 6, 12, and 24 months after completion of radiotherapy
|
|
Head and Neck Cancer-Specific Quality of Life Assessed by the EORTC QLQ-H&N35
Ramy czasowe: Baseline and 3, 6, 12, and 24 months after completion of radiotherapy
|
Head and neck cancer-specific symptoms and quality-of-life problems will be assessed using the EORTC QLQ-H&N35 questionnaire.
Scores are transformed to a 0-100 scale, with higher scores indicating greater symptom burden or more severe problems.
|
Baseline and 3, 6, 12, and 24 months after completion of radiotherapy
|
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Acute Treatment-Related Toxicities
Ramy czasowe: From initiation of treatment through 90 days after completion of radiotherapy
|
The incidence and severity of acute treatment-related toxicities will be assessed and compared between the two treatment groups.
Toxicities will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, as applicable.
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From initiation of treatment through 90 days after completion of radiotherapy
|
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5-Year Cumulative Incidence of Jaw Osteoradionecrosis
Ramy czasowe: Within 60 months after completion of radiotherapy
|
The cumulative incidence of jaw osteoradionecrosis (JORN) within 60 months after completion of radiotherapy will be estimated and compared between the two treatment groups.
|
Within 60 months after completion of radiotherapy
|
|
5-Year Overall Survival
Ramy czasowe: 60 months after randomization
|
The 5-year overall survival rate will be estimated as the probability of remaining alive at 60 months after randomization and compared between the two treatment groups.
|
60 months after randomization
|
|
5-Year Event-Free Survival
Ramy czasowe: 60 months after randomization
|
The 5-year event-free survival rate will be estimated as the probability of remaining free from local recurrence, regional recurrence, distant metastasis, or death from any cause at 60 months after randomization and compared between the two treatment groups.
|
60 months after randomization
|
|
5-Year Local Relapse-Free Survival
Ramy czasowe: 60 months after randomization
|
The 5-year local relapse-free survival rate will be estimated as the probability of remaining free from local recurrence or death from any cause at 60 months after randomization and compared between the two treatment groups.
|
60 months after randomization
|
|
5-Year Regional Relapse-Free Survival
Ramy czasowe: 60 months after randomization
|
The 5-year regional relapse-free survival rate will be estimated as the probability of remaining free from regional recurrence or death from any cause at 60 months after randomization and compared between the two treatment groups.
|
60 months after randomization
|
|
5-Year Distant Metastasis-Free Survival
Ramy czasowe: 60 months after randomization
|
The 5-year distant metastasis-free survival rate will be estimated as the probability of remaining free from distant metastasis or death from any cause at 60 months after randomization and compared between the two treatment groups.
|
60 months after randomization
|
|
Late Treatment-Related Toxicities
Ramy czasowe: From more than 90 days through 60 months after completion of radiotherapy
|
The incidence and severity of late treatment-related toxicities will be assessed and compared between the two treatment groups using the RTOG/EORTC late radiation morbidity scoring criteria and CTCAE version 5.0, as applicable.
|
From more than 90 days through 60 months after completion of radiotherapy
|
Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Min Kang, MD, First Affiliated Hospital of Guangxi Medical University
Publikacje i pomocne linki
Publikacje ogólne
- Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6.
- Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Kubota H, Miyawaki D, Mukumoto N, Ishihara T, Matsumura M, Hasegawa T, Akashi M, Kiyota N, Shinomiya H, Teshima M, Nibu KI, Sasaki R. Risk factors for osteoradionecrosis of the jaw in patients with head and neck squamous cell carcinoma. Radiat Oncol. 2021 Jan 5;16(1):1. doi: 10.1186/s13014-020-01701-5.
- van der Geer SJ, van Rijn PV, Kamstra JI, Langendijk JA, van der Laan BFAM, Roodenburg JLN, Dijkstra PU. Prevalence and prediction of trismus in patients with head and neck cancer: A cross-sectional study. Head Neck. 2019 Jan;41(1):64-71. doi: 10.1002/hed.25369. Epub 2018 Dec 18.
- Yang L, Hong S, Wang Y, Chen H, Liang S, Peng P, Chen Y. Development and External Validation of Nomograms for Predicting Survival in Nasopharyngeal Carcinoma Patients after Definitive Radiotherapy. Sci Rep. 2015 Oct 26;5:15638. doi: 10.1038/srep15638.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby Stomatognatyczne
- Nowotwory według lokalizacji
- Nowotwory
- Choroby zębów
- Nowotwory według typu histologicznego
- Nowotwory głowy i szyi
- Nowotwory gruczołowe i nabłonkowe
- Rak
- Choroby otorynolaryngologiczne
- Nowotwory gardła
- Nowotwory otorynolaryngologiczne
- Choroby jamy nosowo-gardłowej
- Choroby gardła
- Nowotwory jamy nosowo-gardłowej
- Rak jamy nosowo-gardłowej
- Ząb, Uderzający
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- FirstGuangxiMU02
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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