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NCT Number: NCT06095154

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fujian Cancer hospital

Fuzhou, Fujian, 351100, China

Location status: Recruiting

Location contact

Shaojun Lin, DR

CONTACT

About this study

All enrolled patients underwent intensity-modulated radiation therapy (IMRT). The IMRT technique was selected based on the equipment available at each treatment center and the patients' preferences, including IMRT, VMAT, or TOMOTHERAPY. According to our study design, all enrolled patients will be randomly assigned in a 1:1 ratio before radiation therapy. The target area definitions are based on the international ICRU reports No. 50 and No. 60. The specific target area definitions and prescribed doses for the two groups are as follows:

  • GTVp (70Gy/33Fx) Experimental Group: Gross tumor as seen on imaging and nasopharyngoscopy; Control Group: Gross tumor as seen on imaging and nasopharyngoscopy.
  • CTVp1 (60Gy/33Fx) Experimental Group: None; Control Group: GTVp + 5 mm + entire nasopharyngeal mucosa.
  • CTVp2 (54Gy/33Fx) Experimental Group: GTVp + 10 mm + entire nasopharyngeal mucosa; Control Group: GTVp + 10 mm + high-risk anatomical structures.
  • GTVn Experimental Group: Lymph nodes as seen on imaging; Control Group: Lymph nodes as seen on imaging.
  • CTVn Experimental Group: Defined according to CACA/CMDA guidelines; Control Group: Defined according to CACA/CMDA guidelines.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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;
  • Signing informed consent;
  • Follow up regularly and comply with test requirements.

Exclusion criteria

  • 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;
  • Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);
  • Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;
  • Active systemic infection;
  • No or limited capacity for civil conduct;
  • The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
  • Pregnancy or lactation period;

Treatment and study plan

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.

Primary outcomes

  1. Local failure-free survival (LFFS)

    Time frame: 3 years

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

Secondary outcomes

  1. overall survival

    Time frame: 3 years

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

  2. Regional failure-free survival

    Time frame: 3 years

    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.

  3. Distant metastasis-free survival

    Time frame: 3 years

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

  4. Patient's quality-of-life

    Time frame: 3 years

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

Study contacts

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

Qiaojuan Guo, DR

CONTACT

[email protected]

15080013157

Shaojun Lin, DR

CONTACT

[email protected]

13860603879

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Registry information

Official study title

CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma: A Prospective, Multi-center, Randomized Controlled Phase III Clinical Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Oct 23, 2023
Registry last updated
Mar 13, 2025

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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