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

Sponsor

Fujian Cancer Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06136962

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

41.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

Overall survival [10 years]
Overall survival is calculated from diagnosis to death from any cause

Secondary Outcome Measures

Loco-regional failure-free survival [10 years]
Loco-regional failure-free survival is calculated from diagnosis to the first loco-regional failure
Failure-free survival [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
Distant failure-free survival [10 years]
Distant failure-free survival is calculated from diagnosis to the first remote failure
Quality of Life Questionnaires QLQ-C30 [1year]
Quality of life as measured by QLQ-C30
Quality of Life Questionnaires [1year]
Quality of life as measured by QLQ H&N35
Evaluation of late toxicities [1year]
Clinical toxicities will be grade according to RTOG/CTCAE

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of radiation oncology, Fujian cancer hospital	Fuzhou	Fujian	China	350014

Sponsors and Collaborators

Fujian Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fujian Cancer Hospital

ClinicalTrials.gov Identifier:

NCT06136962

Other Study ID Numbers:

NPC011

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Nasopharyngeal Carcinoma

Study Results

No Results Posted as of Nov 18, 2023