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

October 7, 2020 updated by: Fujian Cancer Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

471

Contacts and Locations

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

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Department of radiation oncology, Fujian cancer hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Non-metastatic NPC patients treated with modified reduce-volume target IMRT in our institution

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Modified reduce-volume target IMRT
Patients with newly diagnosed, non-metastatic NPC was given modified reduce-volume target IMRT
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.

What is the study measuring?

Primary Outcome Measures

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

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 (Actual)

June 1, 2020

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

May 10, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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