New-mode Clinical Target Volume Delineation of Nasopharyngeal Carcinoma

November 8, 2023 updated by: Fujian Cancer Hospital

New-mode Clinical Target Volume Delineation and Dosimetric Analysis in Nasopharyngeal Carcinoma Treated With Intensity-Modulated Radiotherapy

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 new-mode reduced volume IMRT versus conventional IMRT, and compare the radiotherapy-related adverse events and quality of life in two groups.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

454

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
  2. No distant metastatic;
  3. Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;
  4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
  5. Signing informed consent;
  6. Follow up regularly and comply with test requirements.

Exclusion Criteria:

  1. Disease progression during IMRT;
  2. Previous malignancy or other concomitant malignant diseases;
  3. The evaluation information of tumor efficacy can not be obtained;
  4. Receive blind treatment in other clinical research;
  5. Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);
  6. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;
  7. Active systemic infection;
  8. No or limited capacity for civil conduct;
  9. 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;
  10. Pregnancy or lactation period;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New-mode reduced CTVp
Patients with newly diagnosed, non-metastatic NPC was given New-mode reduce-volume target IMRT. The CTVp was defined as a subclinical disease consisting of 10 mm margin surrounding GTVnx (not including all nasopharyngeal mucosa)
Radiation: New-mode reduce-volume target IMRT
The CTVp was defined as a subclinical disease consisting of 10 mm margin surrounding GTVnx (not including all nasopharyngeal mucosa)
No Intervention: Conventional CTVp
Patients with newly diagnosed, non-metastatic NPC was given conventional reduce-volume target IMRT. The CTVp was defined as GTVnx + entire nasopharynx mucosa + 10 mm + corresponding anatomical structures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local failure-free survival (LFFS)
Time Frame: 36 months
The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

October 14, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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