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

ConditionNasopharyngeal Carcinoma by AJCC V8 Stage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing University Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Optimized CTVExperimental treatment 1 intervention
Group B: Conventional CTVNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Acute adverse reactions

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

Time frame
3 months
2

Control rate of non-irradiated area

Time frame
36 months

Secondary outcomes

1

Local recurrence-free survival(LRFS)

The duration of time to LRFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.

Time frame
36 months
2

Progress-free survival(PFS)

Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.

Time frame
36 months
3

Overall survival (OS)

Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chongqing University Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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