The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma

April 9, 2024 updated by: Jiangxi Provincial Cancer Hospital

The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma: A Retrospective Study

This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Since the neck target area of nasopharyngeal carcinoma is close to the thyroid gland, the average dose to the thyroid gland is usually around 54Gy, which is difficult to meet the protection requirements for thyroid protection. In the current guidelines, the inner edge of the common carotid artery is used as the inner boundary of the lymph nodes in levels III and IVa, and the lymphatic drainage area needs to include the inner edge of the common carotid artery. Several studies have found that the centers of positive lymph nodes in cervical regions III and IVa are located outside the inner border of the common carotid artery. In order to better protect the thyroid gland, the investigators have improved the delineation of the neck target area. For patients with negative lymph nodes in regions II and IVa (accounting for about 60% of the total patients), a modified neck target volume delineation method was used to define the inner boundary of regions III and IVa as the outer edge of the common carotid artery. For patients with positive lymph nodes in regions III and IVa (accounting for about 40% of the total patients), the inner boundary of regions III and IVa is defined as the inner edge of the common carotid artery or the outer edge of the thyroid. This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area.

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • None Selected
      • Nanchang, None Selected, China, 330029
        • Recruiting
        • Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jingao Li, PhD
        • Sub-Investigator:
          • Xiaochang Gong, PhD
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The pathological diagnosis was newly diagnosed non-keratinizing squamous cell carcinoma nasopharyngeal carcinoma.
  2. The clinical stage is T1-4N0-3M0 (stage I~IVa, UICC/AJCC 8th edition);
  3. There is no history of hypothyroidism or hyperthyroidism before treatment;
  4. Using intensity-modulated radiotherapy technology,
  5. Complete radical dose radiotherapy;
  6. KPS≥70 points;
  7. Age 18-70 years old;
  8. Male or female who is not pregnant or lactating;
  9. Hematological examination: white blood cells > 4×109/L, neutrophils > 2×109/L, hemoglobin > 90g/L, platelets > 100×109/L;
  10. Liver function: ALT, AST < 1.5×ULN, ALP < 2.5×ULN, bilirubin < ULN.
  11. Renal function: creatinine > 60 ml/min;
  12. The patient signs the informed consent form;

Exclusion Criteria:

  1. WHO pathological classification is keratinizing squamous cell carcinoma or basaloid carcinoma;
  2. palliative treatment;
  3. Have a history of other malignant tumors;
  4. Pregnant or lactating women (women of childbearing age should consider taking a pregnancy test, and patients are required to use effective contraception during treatment);
  5. Have a history of neck surgery;
  6. Have a history of hyperthyroidism or hypothyroidism.
  7. Previous history of head and neck radiation therapy;

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: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified neck target volume delineation
For patients with negative lymph nodes in regions III and IVa, a modified neck target volume delineation method was used to define the inner boundary of regions III and IVa as the outer edge of the common carotid artery.
Radiation: Modified neck target volume delineation
Modified neck target volume delineation method was used to define the inner boundary of regions III and IVa as the outer edge of the common carotid artery.
No Intervention: Routine neck target volume delineation
For patients with negative lymph nodes in regions III and IVa, the inner boundary of regions III and IVa is defined as the inner edge of the common carotid artery or the outer edge of the thyroid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional Recurrence-free Survival
Time Frame: 3 years
From the date of diagnosis to the day of date of diagnosis and the date of regional relapse
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation-induced hypothyroidism
Time Frame: 3 years
From the date of diagnosis to the day of date of diagnosis and the date of regional TSH > upper limit of normal, FT4 normal or less than < lower limit of normal
3 years
Overall Survival
Time Frame: 3 years
From the date of diagnosis to any death, with patients unavailable for follow-up censored at the date of last follow-up
3 years
Progression-free Survival
Time Frame: 3 years
From the date of diagnosis to the data of tumor progression or death (for any cause)
3 years

Collaborators and Investigators

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

Sponsor

Jiangxi Provincial 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 (Actual)

January 1, 2019

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-Thyroid function

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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