About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Omission of Prophylactic Impacted Tooth Extraction
- Prophylactic Impacted Tooth Extraction
Treatment groups
Sponsors and collaborators
First Affiliated Hospital of Guangxi Medical University
Lead sponsor
People's Hospital of Guangxi Zhuang Autonomous Region
Collaborator
LiuZhou People's Hospital
Collaborator
Liuzhou Workers' Hospital
Collaborator
Wuzhou Red Cross Hospital
Collaborator
Guigang People's Hospital
Collaborator
First People's Hospital of Yulin
Collaborator
Affiliated Hospital of Guilin University
Collaborator
Youjiang Medical College for Nationalities
Collaborator