Nasopharyngeal Carcinoma Treated With Reduced Volume Intensity Modulated Radiation Therapy:10-Year Outcome and Late Toxicity, Quality of Life

November 16, 2023 updated by: Fujian Cancer Hospital

A Comprehensive Prospective Study on the 10-Year Outcome and Late Toxicity, Quality of Life of Reduced Volume Intensity Modulated Radiation Therapy in Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. The last three decades of research in head and neck radiation oncology have largely focused on improvements in survival, which have mostly come at the cost of long term toxicity for surviving patients.This is an observational study that is being done to evaluate the long-term efficacy, learn about the toxicity and quality of life that survivors of nasopharyngeal carcinoma may have following treated with reduced volume intensity modulated radiation therapy.

Study Overview

Status

Not yet recruiting

Conditions

Nasopharyngeal Carcinoma

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

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

Study Contact

Name: Qiaojuan Guo, MD
Phone Number: 15080013157
Email: guoqiaojuan@163.com

Study Contact Backup

Name: Lin Shaojun, MD
Phone Number: 13860603879
Email: linshaojun@yeah.net

Study Locations

China
- Fujian
  - Fuzhou, Fujian, China, 350014
    - Department of radiation oncology, Fujian cancer hospital
    - Contact:
      
      Shaojun Lin, doctor
      
      Phone Number: 0591-62752225
      
      Email: linshaojun@yeah.com

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

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Histologically diagnosed non-metastatic Nasopharyngeal carcinoma (NPC) patients who were treated with Reduced Volume Intensity Modulated Radiation Therapy.

Description

Inclusion Criteria:

Received treatment with Reduced Volume Intensity Modulated Radiation Therapy
Age 18 or above, upper limit 65
Ability to comply with the protocol

Exclusion Criteria:

History of recurrent nasopharyngeal disease
A history of any physical, psychological or social condition which would impair with the ability of the patient to cooperate in this study
Unable to provide consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival Time Frame: 10 years	Overall survival is calculated from diagnosis to death from any cause	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loco-regional failure-free survival Time Frame: 10 years	Loco-regional failure-free survival is calculated from diagnosis to the first loco-regional failure	10 years
Failure-free survival Time Frame: 10 years	Failure-free survival rate is calculated from the date of diagnosis to the date of treatment failure or death from any cause, whichever is first	10 years
Distant failure-free survival Time Frame: 10 years	Distant failure-free survival is calculated from diagnosis to the first remote failure	10 years
Quality of Life Questionnaires QLQ-C30 Time Frame: 1year	Quality of life as measured by QLQ-C30	1year
Quality of Life Questionnaires Time Frame: 1year	Quality of life as measured by QLQ H&N35	1year
Evaluation of late toxicities Time Frame: 1year	Clinical toxicities will be grade according to RTOG/CTCAE	1year

Collaborators and Investigators

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

Sponsor

Fujian Cancer Hospital

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 (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 5, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Estimated)

November 17, 2023

Study Record Updates

Last Update Posted (Estimated)