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

Not yet recruiting

• Conditions: Nasopharyngeal Carcinoma

• Registration Number: NCT06136962
• Lead Sponsor: Fujian Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-05
• Study First Submitted QC: 2023-11-16
• Last Update Submitted: 2023-11-16
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Study Start: 2023-12-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	10 years	Overall survival is calculated from diagnosis to death from any cause

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of radiation oncology, Fujian cancer hospital; 🇨🇳 Fuzhou, Fujian, China