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

PHASE3CompletedINTERVENTIONAL
Enrollment

179

Participants

Timeline

Start Date

January 30, 2018

Primary Completion Date

December 28, 2021

Study Completion Date

January 31, 2024

Conditions
Oral Mucositis (Ulcerative) Due to Radiation
Interventions
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)."

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."

Trial Locations (1)

Unknown

Cancer Center, Sun Yat-sen University, Guangzhou

All Listed Sponsors
collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

collaborator

First People's Hospital of Foshan

OTHER

collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

lead

Sun Yat-sen University

OTHER

NCT03387774 - Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients | Biotech Hunter | Biotech Hunter