Status:
RECRUITING
Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
First Affiliated Hospital of Guangxi Medical University
Conditions:
Nasopharyngeal Cancinoma (NPC)
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
To evaluate the locoregional control, survival rate, toxicity, and quality of life in patients with nasopharyngeal carcinoma treated with reduced prophylactic irradiation doses to the Low-Risk Clinica...
Detailed Description
This phase 3, multicenter, non-inferiority, randomized controlled clinical trial recruits patients with newly diagnosed, untreated, non-distant metastatic, non-keratinizing nasopharyngeal carcinoma (N...
Eligibility Criteria
Inclusion
- Newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; aged between 18 and 70 years; Eastern Cooperative Oncology Group performance score of 0-1; adequate hematologic function (neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥100×109/L, and hemoglobin≥ 90 g/L); adequate renal function (creatinine ≤ 1.5 upper limit of normal \[ULN\]) or calculated creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); and adequate hepatic function (serum bilirubin ≤ 2.0×ULN, and alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN).
Exclusion
- Previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy (except for cured basal cell carcinoma or carcinoma in situ of the cervix); lactation or pregnancy; or severe coexisting illness.
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Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2032
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT07201337
Start Date
November 1 2025
End Date
November 1 2032
Last Update
November 17 2025
Active Locations (1)
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1
Sun yat-sen university cancer center
Guangzhou, Guangdong, China, 510060