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Trial Title:
The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma
NCT ID:
NCT06268600
Condition:
Nasopharyngeal Carcinoma
Nasopharyngeal Cancer
Hypothyroidism
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Hypothyroidism
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Modified neck target volume delineation
Description:
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.
Arm group label:
Modified neck target volume delineation
Summary:
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.
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.
Criteria for eligibility:
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Contact:
Last name:
Tianzhu Lu
Phone:
8615270186250
Email:
lutianzhu2008@163.com
Contact backup:
Phone ext:
Li
Email:
lijingao@hotmail.com
Investigator:
Last name:
Jingao Li, PhD
Email:
Principal Investigator
Investigator:
Last name:
Xiaochang Gong, PhD
Email:
Sub-Investigator
Start date:
January 1, 2019
Completion date:
November 30, 2025
Lead sponsor:
Agency:
Jiangxi Provincial Cancer Hospital
Agency class:
Other
Source:
Jiangxi Provincial Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06268600
