Nasopharyngeal Carcinoma Clinical Trial
Official title:
The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma: A Retrospective Study
Verified date | April 2024 |
Source | Jiangxi Provincial Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 320 |
Est. completion date | November 30, 2025 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
China | Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital | Nanchang | None Selected |
Lead Sponsor | Collaborator |
---|---|
Jiangxi Provincial Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Radiation-induced hypothyroidism | 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 | |
Secondary | Overall Survival | From the date of diagnosis to any death, with patients unavailable for follow-up censored at the date of last follow-up | 3 years | |
Secondary | Progression-free Survival | From the date of diagnosis to the data of tumor progression or death (for any cause) | 3 years |
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