Hypofractionated Radiotherapy for Nasopharyngeal Carcinoma

NCT06796270 | Recruiting

• 1 other identifier: 2024-K52-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

Nasopharyngeal Carcinoma (NPC); Hypofractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  overall response rate (ORR) in patients with nasopharyngeal carcinoma treated with Hypofractionated radiotherapy

  3 months， 6 months，12 months，24 months，36 months，60 months

Secondary Outcomes (6)

• Overall survival (months)

  3 months， 6 months，12 months，24 months，36 months，60 months

• Progress-free survival (months)

  3 months， 6 months，12 months，24 months，36 months，60 months

• Number acute toxicities

  1-2 weeks, 3 months, 6 months

• Number of chronic toxicities

  2 weeks, 3 months, 6 months and 12 months

• Patient reported Health related quality of life (HRQoL)

  2 months

Study Arms (1)

Hypofractionated radiotherapy

EXPERIMENTAL

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.

Radiation: Hypofractionated radiotherapy

Interventions

Hypofractionated radiotherapy RADIATION

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.

Hypofractionated radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years, male or female；
• Performance status ≤ 2 ;
• Nasopharyngeal cancer patients diagnosed by pathology (including histology or cytology) , of nasopharyngeal non-keratonic carcinoma (differentiated or undifferentiated, whether TNM staging);
• Have at least one evaluable lesion (according to Recist1.1 criteria)
• Expected survival ≥6 months.
• 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.
• 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.

You may not qualify if:

• Pregnant or lactating women
• As determined by the investigators, there were severe comorbidities that could not tolerate or complete radiation therapy.
• There are contraindications in MRI;
• Second primary malignancy exists;
• Patients with severe complications,such as hypertension, coronary heart disease,mental disease or patients who had any allergies before;
• Received any other research in the past 4 weeks before enrollment.

Sponsors & Collaborators

• The Second Affiliated Hospital of Hainan Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570311, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• yuecan zeng, doctor

  The Second Affiliated Hospital of Hainan Medical University

  STUDY DIRECTOR

Central Study Contacts

yuecan zeng, doctor

CONTACT

19946610752; wellyy2005@hainmc.edu.cn

junnv xu, doctor

CONTACT

18208946196; xujunnv@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 28, 2025
• Study Start: February 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

CN (1)