Health TrialsbyHealthPanel

CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma

ConditionNasopharyngeal Carcinoma by AJCC V8 Stage
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFujian Cancer Hospital

About this trial

This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The aim of this study is to evaluate the efficacy and safety of modified IMRT, of which CTV delineation was only based on geometric expansion from GTV.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

No distant metastatic;

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

Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;

Disqualifiers

Disease progression during IMRT;

Previous malignancy or other concomitant malignant diseases;

The evaluation information of tumor efficacy can not be obtained;

Receive blind treatment in other clinical research;

Trial design

Design model

Parallel

Treatments tested in this trial

  • CTV Delineation Based on Geometric Expansion From GTV in Nasopharyngeal Carcinoma

    Radiation

    CTVp2 is generated by expanding GTVp by 10 mm and including the nasopharyngeal mucosa.

Treatment groups

474 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Local failure-free survival (LFFS)

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

Time frame
3 years

Secondary outcomes

1

overall survival

time from the date of the start of chemotherapy to death due to any cause

Time frame
3 years
2

Regional failure-free survival

The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.

Time frame
3 years
3

Distant metastasis-free survival

The distant metastasis-free survival rate will be estimated using Kaplan-Meier

Time frame
3 years
4

Patient's quality-of-life

uropean Organization for Research and Treatment of Cancer Quality-of-Life Head

Time frame
3 years

Other outcomes

Sponsors and contacts

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

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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