To Evaluate the Efficacy and Feasibility of Modified Reduce-volume Target IMRT in the Treatment of Patients With Non-metastatic NPC

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Retrospective Real-world Study in Patients With Nasopharyngeal Carcinoma: to Evaluate the Efficacy and Feasibility of Modified Reduce-volume Target IMRT in the Treatment of Patients With Non-metastatic NPC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387266
• Other study ID #: NPC004
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: Fujian Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective real-world study to evaluate the efficacy and feasibility of modified reduce-volume target IMRT in the treatment of patients with non-metastatic NPC

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: October 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;

2. Newly diagnosed, non-metastatic and treated with modified reduce-volume IMRT;

3. Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;

4. Diagnosis time: November 1, 2014 to December 31 , 2017

Exclusion Criteria:

1. Disease progression during IMRT;

2. Previous malignancy or other concomitant malignant diseases;

3. The evaluation information of tumor efficacy can not be obtained;

4. Receive blind treatment in other clinical research.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• modified reduce-volume target IMRT
The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTVnx was defined as GTVnx + nasopharynx mucosa + 8mm +corresponding anatomical structure without the delineation of CTV1. The CTVnd was defined as GTVnd plus the elective neck area. The prescribe doses of GTVnx/GTVnd, CTVnx, CTVnd were 66-70Gy,54-56Gy and 50-54Gy in 31-35 fractions, respectively.

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	Local failure-free survival (LFFS)	The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure.	60 month