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NCT Number: NCT06167109

NBI Combined With MRI to Guide CTV Optimization 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location status: Recruiting

Location contact

Ying Wang, Ph.D, M. D.

CONTACT

[email protected]

13996412826

Ying Wang, Ph.D, M. D.

PRINCIPAL_INVESTIGATOR

Yuwei Wang, M.M.

CONTACT

[email protected]

13436161758

Yuwei Wang, M.M.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CTV optimized IMRT

Radiation

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.

Primary outcomes

  1. Acute adverse reactions

    Time frame: 3 months

    The acute adverse reactions of patients during or after radiotherapy were evaluated with the corresponding standard scales.

  2. Control rate of non-irradiated area

    Time frame: 36 months

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Wang, Ph.D,M.D.

CONTACT

[email protected]

13996412826

Yuwei Wang, M.M.

CONTACT

[email protected]

13436161758

Sponsors and collaborators

Lead sponsor

Chongqing University Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2023
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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