The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma

NCT06268600 | Recruiting

• 1 other identifier: NPC-Thyroid function
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma; Nasopharyngeal Cancer; Hypothyroidism

Outcome Measures

Primary Outcomes (1)

• Regional Recurrence-free Survival

  From the date of diagnosis to the day of date of diagnosis and the date of regional relapse

  3 years

Secondary Outcomes (3)

• Radiation-induced hypothyroidism

  3 years

• Overall Survival

  3 years

• Progression-free Survival

  3 years

Study Arms (2)

Modified neck target volume delineation

EXPERIMENTAL

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

Routine neck target volume delineation

NO INTERVENTION

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.

Interventions

Modified neck target volume delineation 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.

Modified neck target volume delineation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital

Nanchang, None Selected, 330029, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Hypothyroidism

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Thyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: January 1, 2019
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

CN (1)