Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC

Launched by JIANGXI PROVINCIAL CANCER HOSPITAL · Dec 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to radiotherapy for patients with nasopharyngeal carcinoma, which is a type of cancer that occurs in the throat area behind the nose. The goal is to see if a modified way of targeting the radiation can better protect the thyroid gland, which is important for hormone production and overall health. The trial will compare this new method with the standard treatment to see which one leads to fewer cases of hypothyroidism (an underactive thyroid) and assesses the quality of life and any side effects experienced by patients.

To participate in this trial, individuals need to be between 18 and 70 years old and have been diagnosed with nasopharyngeal carcinoma without any signs of distant spread or prior treatments. Participants should have normal thyroid function and meet certain health criteria, ensuring they can safely undergo the treatment. If eligible, participants will receive either the new or standard radiotherapy and will be monitored for their thyroid function and overall well-being. This study is currently recruiting participants, and those who join will contribute valuable information that could improve cancer treatment and quality of life for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female, aged 18-70 years; 2. Pathologically confirmed nasopharyngeal carcinoma; 3. No positive lymph nodes in unilateral or bilateral regions III and IVa; 4. Clinical stage I-IVa (AJCC/UICC 8th edition), with no evidence of distant metastasis; 5. Normal thyroid function; 6. ECOG performance status of 0-1; 7. Treatment-naïve patients who have not received any prior antitumor therapy; 6. No contraindications to radiotherapy or chemotherapy; 9. Adequate organ function, meeting the following criteria: Hematologic criteria: WBC ≥ 4.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L (no transfusion, blood products, or hematopoietic growth factors used within the past 7 days); Biochemical criteria: ALT and AST \< 1.5 × ULN, ALP \< 2.5 × ULN, total bilirubin \< ULN, BUN and creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).
• • 10. Voluntarily agreed to participate in the study, signed the informed consent form, demonstrated good compliance, and agreed to follow-up.
• Exclusion Criteria:
• • 1. History of other malignant tumors (excluding basal cell carcinoma/squamous cell carcinoma of the skin or cervical carcinoma in situ);
• • 2. History of radiotherapy (excluding radiotherapy outside the planned target area for conditions such as melanoma);
• • 3. History of neck surgery;
• • 4. Any severe comorbidities that may pose risks to the study or affect compliance, such as unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \> 1.5 × ULN), or psychiatric disorders;
• • 5. History of hyperthyroidism, hypothyroidism, or immune-related thyroid disorders;
• • 6. Other family or social factors, as judged by the investigator, may force the study's early termination, compromise patient safety, or affect the collection of trial data.