The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma

NCT ID: NCT06268600

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2025-11-30

Brief 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.

Conditions

Nasopharyngeal Carcinoma; Nasopharyngeal Cancer; Hypothyroidism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Modified neck target volume delineation

Intervention Type: RADIATION

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: RADIATION

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital

Nanchang, None Selected, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Tianzhu Lu

Role: primary

lutianzhu2008@163.com

8615270186250

Role: backup

lijingao@hotmail.com

Other Identifiers

NPC-Thyroid function

Identifier Type: -

Identifier Source: org_study_id