Massive Nasal Bleeding in Patients With NPC Received Curative RT

March 31, 2024 updated by: Hao-Shen Cheng, Taichung Veterans General Hospital

Massive Nasal Bleeding in Patients With Nasopharyngeal Carcinoma Received Curative Radiotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1327

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • incomplete record of history or treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NPC received Curative radiotherapy
Other: Patients without massive nasal bleeding
No event of massive nasal bleeding after curative radiotherapy
Other: Patients with massive nasal bleeding
Any event of massive nasal bleeding after curative radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Massive Nasal Bleeding Rate
Time Frame: From date of radiotherapy until the date of first documented massive bleeding, assessed up to 360 months
Massive Nasal Bleeding Rate among different characteristics. Massive Nasal Bleeding was defined as unique blood loss > 300 ml or recurrent blood losses > 100 ml.
From date of radiotherapy until the date of first documented massive bleeding, assessed up to 360 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 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
Overall Survival
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 1994

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 31, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHTCCTC_NPCbleeding001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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