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

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06136962
• Other study ID #: NPC011
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Fujian Cancer Hospital
• Contact: Lin Shaojun, MD
• Phone: 13860603879
• Email: linshaojun[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Locations

Country	Name	City	State
China	Department of radiation oncology, Fujian cancer hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival is calculated from diagnosis to death from any cause	10 years
Secondary	Loco-regional failure-free survival	Loco-regional failure-free survival is calculated from diagnosis to the first loco-regional failure	10 years
Secondary	Failure-free survival	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
Secondary	Distant failure-free survival	Distant failure-free survival is calculated from diagnosis to the first remote failure	10 years
Secondary	Quality of Life Questionnaires QLQ-C30	Quality of life as measured by QLQ-C30	1year
Secondary	Quality of Life Questionnaires	Quality of life as measured by QLQ H&N35	1year
Secondary	Evaluation of late toxicities	Clinical toxicities will be grade according to RTOG/CTCAE	1year