RecruitingPhase 3NCT06095154

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

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


Sponsor

Fujian Cancer Hospital

Enrollment

474 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

  • 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 Criteria10

  • 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;

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Interventions

RADIATIONCTV Delineation Based on Geometric Expansion From GTV in Nasopharyngeal Carcinoma

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


Locations(1)

Fujian Cancer hospital

Fuzhou, Fujian, China

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NCT06095154


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