The Second Affiliated Hospital of Hainan Medical University
Phase
Not applicable
Started
2026-02-20
Last updated
2025-01-28
Condition(s) studied
Nasopharyngeal Carcinoma (NPC)
Investigational drug(s) / intervention(s)
Hypofractionated radiotherapy
Hypofractionated radiotherapy: The patients with nasopharyngeal carcinoma were given the dose of large segmentation radiotherapy, 2.64Gy/ time, 5 times/week, a total of 25 times, a total of 66Gy/5 weeks.
Study summary
The purpose of this study was to evaluate the efficacy and safety of large fractionation radiotherapy in nasopharyngeal carcinoma patients, and to analyze whether Hypofractionated radiotherapy is not inferior to conventional radiotherapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-75 years, male or female;
2. Performance status ≤ 2 ;
3. Nasopharyngeal cancer patients diagnosed by pathology (including histology or cytology) , of nasopharyngeal non-keratonic carcinoma (differentiated or undifferentiated, whether TNM staging);
4. Have at least one evaluable lesion (according to Recist1.1 criteria)
5. Expected survival ≥6 months.
6. The main organs are functioning normally and meet the following standards: (1) Blood routine examination must meet the following criteria: (no blood transfusion within 14 days) a. HB ≥ 100g/L, b. WBC ≥3×10\^9/L c. ANC≥1.5×10\^9/L, d. PLT ≥100×10\^9/L; (2) Biochemical examination must meet the following standards: a. BIL\<1.5 times the upper limit of normal value (ULN), b. ALT and AST\<2.5ULN, GPT ≤1.5×ULN; c. Serum Cr≤1 ULN, endogenous creatinine clearance rate\>60ml/min (Cockcroft Gault formula);(3).Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;(4).The myocardial enzyme spectra were in the normal range.
7. Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the Clinical Investigation Plan tests and procedures.
Exclusion Criteria:
1. Pregnant or lactating women
2. As determined by the investigators, there were severe comorbidities that could not tolerate or complete radiation therapy.
3. There are contraindications in MRI;
4. Second primary malignancy exists;
5. Patients with severe complications,such as hypertension, coronary heart disease,mental disease or patients who had any allergies before;
6. Received any other research in the past 4 weeks before enrollment.
Primary outcome measure(s)
Objective response rate (ORR) — 3 months, 6 months,12 months,24 months,36 months,60 months overall response rate (ORR) in patients with nasopharyngeal carcinoma treated with Hypofractionated radiotherapy
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Hainan Medical University
Haikou
Hainan
Recruiting
More The Second Affiliated Hospital of Hainan Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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