Clinical trial NCT06348485: Massive Nasal Bleeding in Patients With NPC Received Curative RT
Official title: Massive Nasal Bleeding in Patients With Nasopharyngeal Carcinoma Received Curative Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasopharyngeal Carcinoma Patients Treated With Curative Radiotherapy
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 1327
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 1327 patients with previously untreated, biopsy-proven NPC, and no distant metastasis were retrospective reviewed. There are 957 males and 370 females received conventional 2D or 3D conformal radiotherapy.

Brief summary: To investigate the incidence, predictive markers, and survival impact of massive nasal bleeding in nasopharyngeal carcinoma (NPC) patients who received curative radiotherapy (RT) with/without chemotherapy. A total of 1327 patients with previously untreated, biopsy-proven NPC, and no distant metastasis were retrospective reviewed. Investigators analyzed the occurrence rates of massive nasal bleeding between different characteristics and tried to identify important predictive factors. Investigators compared overall survival between patients with and without massive nasal bleeding by Kaplan-Meier method.


Eligibility criteria: Inclusion Criteria:

* previously untreated, biopsy-proven NPC
* no distant metastasis

Exclusion Criteria:

* incomplete record of history or treatment

Primary outcomes:
measure: Massive Nasal Bleeding Rate
timeFrame: From date of radiotherapy until the date of first documented massive bleeding, assessed up to 360 months
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of radiotherapy until the date of last clinic visit or date of death from any cause, whichever came first, assessed up to 360 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References:
citation: Huang Y, Yan D, Wang M, Chen S, Yang F. Clinicopathological factors affecting the prognosis of massive hemorrhage after radiotherapy for patients having nasopharyngeal carcinoma. J Cancer Res Ther. 2021 Nov;17(5):1219-1224. doi: 10.4103/jcrt.jcrt_586_21.
citation: Zhan J, Zhang S, Wei X, Fu Y, Zheng J. Etiology and management of nasopharyngeal hemorrhage after radiotherapy for nasopharyngeal carcinoma. Cancer Manag Res. 2019 Mar 15;11:2171-2178. doi: 10.2147/CMAR.S183537. eCollection 2019.
citation: Li J, Yi X, He G, Yao D, Bin X, Feng Y, Niu Z, Tan Q, Tang A. Analysis of the risk of death and clinical management for nasal or nasopharyngeal bleeding occurring after radiotherapy for nasopharyngeal carcinoma. Auris Nasus Larynx. 2022 Aug;49(4):703-708. doi: 10.1016/j.anl.2022.01.006. Epub 2022 Jan 20.
citation: Zeng L, Wan W, Luo Q, Jiang H, Ye J. Retrospective analysis of massive epistaxis and pseudoaneurysms in nasopharyngeal carcinoma after radiotherapy. Eur Arch Otorhinolaryngol. 2022 Jun;279(6):2973-2980. doi: 10.1007/s00405-021-07111-x. Epub 2021 Oct 8.