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Clinical study on efficacy and safety of large fractionated radiotherapy in patients with nasopharyngeal carcinoma

Clinical study on efficacy and safety of large fractionated radiotherapy in patients with nasopharyngeal carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099451
Enrollment
Unknown
Registered
2025-03-24
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal cancer

Interventions

Large-fraction radiotherapy group:Hypofractionated radiotherapy dose of 2.64Gy/time, 5 times/week, for a total of 25 doses, with a total of 66Gy/5 weeks, was administered to patients with nasopharynge

Sponsors

The Second Affiliated Hospital of Hainan Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. ECOG score 0-2; 2. Age 18-75 years, male or non-pregnant female; 3. Pathologic diagnosis of nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, regardless of TNM stage); 4. Have at least one evaluable lesion (according to RECIST1.1 criteria); 5. Expected survival time>=6 months; 6. The functional level of major organs meets the following criteria: (1) hematology: WBC>=3.0×109/L, ANC>=1.5×10^9/L, PLT >=100×10^9/L, HGB>=90g/L; (2) Liver function: ALT, AST=60ml/min (Cockcroft-Gault formula); (4) Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; (5) Cardiac enzyme spectrum within the normal range; 7. The patient has signed the informed notice and is willing and able to comply with the visits, treatment plans, and laboratory tests of the study plan.

Exclusion criteria

Exclusion criteria: 1. Severe comorbidities judged by the investigator to be intolerant or complete radiotherapy; 2. There are contraindications to magnetic resonance examination; 3. Presence of acute inflammation requiring systemic therapy; 4. In the active period of infectious diseases; 5. Pregnant women, lactating women, and patients with birth plans during the study; 6. Participation in other clinical trials currently or within 4 weeks prior to enrollment; 7. Inability to comply with the study protocol and follow-up procedures; 8. Any other disease, metabolic disorder, physical examination findings, or abnormal laboratory test results as judged by the investigator and with reasonable suspicion of diseases or conditions that may cause contraindications to the use of the study treatment regimen, or affect the reliability of the study results, or put the patient at high risk of treatment complications.

Design outcomes

Primary

MeasureTime frame
ORR;

Countries

China

Contacts

Public ContactYuecan Zeng

The Second Affiliated Hospital of Hainan Medical University

wellyy2005@hainmc.edu.cn+86 19946610752

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026