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Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients

NCT03387774 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2026-05-07

No results posted yet for this study

Summary

This is a phase 3, open-label, multicenter, randomized controlled phase III clinical trial. The purpose of this study is to evaluate the efficacy of ulinastatin, a kind of protease inhibitor, in the treatment of radiation-induced acute oral mucositis in localregionally advanced nasopharyngeal carcinoma(NPC) patients treated with concurrent chemoradiotherapy(CCRT). To Explore a new and efficient way to reduce the incidence and severity of radiation-induced acute oral mucositis.

Conditions

  • Oral Mucositis (Ulcerative) Due to Radiation

Interventions

DRUG

Ulinastatin

Patients in the experimental group were received ulinastatin: Ulinastatin (UTI): ulinastatin was intravenous drip at a dose of one hundred thousand units added to 100 ml of 0.9% normal saline every time, 3 times every radiation day, and until the end of radiotherapy.

DRUG

Cisplatin

Patients in both arms received concurrent cisplatin chemotherapy: 100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.

RADIATION

Intensity Modulated Radiation Therapy

Patients in both arms received Intensity Modulated Radiation Therapy: All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 50 and 62. The prescribed dose was 68-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-68 Gy to GTVnd (Gross tumor volume of the cervical lymph node), 60- 64Gy to PTVnd and PTV1 (Planning target volume 1), and 54-58 Gy to PTV2 (Planning target volume 2) in 30-32 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).

Sponsors & Collaborators

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    collaborator OTHER

  • First People's Hospital of Foshan

    collaborator OTHER

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • zhao chong · Sun Yat-Sen University Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2021-12-28
Completion
2024-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03387774 on ClinicalTrials.gov