NBI Combined With MRI to Guide CTV Optimization in Eccentric Nasopharyngeal Carcinoma

December 4, 2023 updated by: Ying Wang, Chongqing University Cancer Hospital

Endoscopic NBI Combined With MRI to Guide the Optimization of Clinical Target Volume Delineation in Eccentric Nasopharyngeal Carcinoma

This is a prospective, single-center clinical trial in eccentric nasopharyngeal carcinoma (NPC) patients. The aim of this study is to evaluate the efficacy and safety of NBI combined with MRI-guided optimized CTV compared with conventional CTV, and to compare the radiotherapy-related adverse events and quality of life between the two groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients with eccentric nasopharyngeal carcinoma were selected on the basis of MRI findings and NBI endoscopy was performed in these patients. The patients were enrolled if both NBI endoscopy and MRI showed eccentric NPC. Patients with contralateral tissue mucosal abnormalities detected by NBI and confirmed by biopsy were excluded. Then the patients were randomly divided into an experimental group (Optimized CTV) or a control group (Conventional CTV) to evaluate the efficacy and safety of the two groups, as well as radiotherapy-related adverse events.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ying Wang, Ph.D, M. D.
        • Sub-Investigator:
          • Yuwei Wang, M.M.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males and females ≥18 years of age;
  2. ECOG Performance Status 0,1 or 2;
  3. Pathologically diagnosed as nasopharyngeal carcinoma;
  4. Pretreatment nasopharynx and neck MRI imaging;
  5. Nasopharyngeal suspected lesions were examined by NBI endoscopy;
  6. Meeting the definition of eccentric NPC with ipsilateral (affected side) staging of T1-4 and contralateral (healthy side) staging of T0;
  7. Patients evaluated without contraindications to radiotherapy;
  8. Voluntary participation in clinical research, and signed informed consent.

Exclusion Criteria:

  1. Patients who did not successfully undergo all three examinations (MRI, NBI, and endoscopic biopsy);
  2. Other rare pathological types, such as adenocarcinoma;
  3. Patients with tumor invasion of the clivus;
  4. Patients whose contralateral retropharyngeal lymph nodes met the diagnostic criteria;
  5. Invasion of paranasal sinuses (except simple sphenoid invasion).

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Optimized CTV
The contralateral CTV1 was defined as a subclinical disease consisting of 5mm margin surrounding GTVnx.The CTV2 was defined as potentially involved regions consisting of 5mm margin surrounding CTV1, and contralateral CTV2 only included the pharyngeal recess.
Radiation: CTV optimized IMRT
The contralateral CTV1 was defined as a subclinical disease consisting of 5mm margin surrounding GTVnx.The CTV2 was defined as a potentially involved regions consisting of 5mm margin surrounding CTV1, and contralateral CTV2 only included the pharyngeal recess.
No Intervention: Conventional CTV
The CTV1 was defined as GTVnx + 5 mm + entire nasopharynx mucosa .The CTV2 was defined as GTV1+ 5 mm + corresponding anatomical structures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute adverse reactions
Time Frame: 3 months
The acute adverse reactions of patients during or after radiotherapy were evaluated with the corresponding standard scales.
3 months
Control rate of non-irradiated area
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local recurrence-free survival(LRFS)
Time Frame: 36 months
The duration of time to LRFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.
36 months
Progress-free survival(PFS)
Time Frame: 36 months
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
36 months
Overall survival (OS)
Time Frame: 36 months
Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing University Cancer Hospital

Investigators

  • Principal Investigator: Ying Wang, Ph.D, M.D., Chongqing University 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)

October 20, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Estimated)

December 12, 2023

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-CTV

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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