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

NCT03387774 | Completed Phase 3 DMC

• 1 other identifier: UTI-RTOM-NPC
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ulinastatin; Radiation-induced acute oral mucositis; Localregionally Advanced Nasopharyngeal Carcinoma; Intensity Modulated Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of Severe Acute Oral Mucositis (Grade of CTC-AE ≥ 3)

  The primary outcome measures planned in the protocol were the incidence of actue oral mucositis grade greater than or equal to 3 using the Common Terminology Criteria for Adverse Events of Version 4.03 (CTCAE 4.03) in the experimental group and control group. CTCAE 4.03 grade 3 = severe pain; interfering with oral; CTCAE 4.03 grade 4 = Life-threatening consequences; urgent intervention indicated; CTCAE 4.03 grade 5 = death. Mucositis will be assessed weely during concurrent chemoradiotherapy (CCRT) for 7 weeks, and assessed once at 1 month after CCRT and 3 months after CCRT, respectively. The whole observation time may up to 19 weeks.

  Up to 19 weeks

Secondary Outcomes (9)

• Weeks to Onset of Severe Radiation-Induced Acute Oral Mucositis (Grade of CTCAE ≥ 3)

  Up to Week 19

• Oral Assessment Guide (OAG) Score

  Up to 19 weeks

• Oral Mucositis Scores by World Health Organization (WHO)

  Up to 19 weeks

• Rate of Participants With Unplanned Breaks in Radiotherapy

  During the 7 weeks for concurrent chemoradiotherapy

• Quality of Life with EORTC QLQ-C30

  Up to 19 weeks

Study Arms (2)

Concurrent chemoradiotherapy and ulinastatin

EXPERIMENTAL

Concurrent chemoradiotherapy (CCRT) and intravenous drip of ulinastatin, the details are as follows: 1. Intensity modulated radiation therapy combined with concurrent chemotherapy of cisplatin 100mg/m2 on day 1 and day 22 of RT; 2. Ulinastatin through intravenous drip at a dose of one hundred thousand units added to 100 ml of 0.9% normal saline, 3 times every radiation day, until the end of radiotherapy.

Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy; Drug: Ulinastatin

Concurrent chemoradiotherapy

ACTIVE COMPARATOR

Concurrent chemoradiotherapy (CCRT) alone: Intensity modulated radiation therapy combined with concurrent chemotherapy of cisplatin 100mg/m2 on day 1 and day 22 of RT.

Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy

Interventions

Cisplatin DRUG

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

Also known as: DDP

Concurrent chemoradiotherapy; Concurrent chemoradiotherapy and ulinastatin

Intensity Modulated Radiation Therapy RADIATION

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).

Also known as: IMRT

Concurrent chemoradiotherapy; Concurrent chemoradiotherapy and ulinastatin

Ulinastatin DRUG

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.

Also known as: UTI for injection

Concurrent chemoradiotherapy and ulinastatin

Eligibility Criteria

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

You may qualify if:

• Newly histologic diagnosis of nasopharyngeal carcinoma without distant metastasis
• Clinical stage III\~IVa( UICC (Union International Against Cancer) /AJCC (American Joint Committee on Cancer) TNM staging system 8th edition)
• Karnofsky Performance Status Scale between 80-100
• WBC count ≥ 4×109/L，neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L， platelet count ≥ 100×109/L
• ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
• Sign the informed consent.

You may not qualify if:

• Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas
• Younger than 18 years old or older than 70 years old
• Pregnancy or lactation
• Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
• Have suffered from other tumor or now suffering from other tumor
• Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases
• Refuse to give up smoking/drinking/betel chewing
• suffering from other active infection diseases and in need of treatment.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator
• First People's Hospital of Foshan: collaborator
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Related Links

• Home Page of Cancer Center, Sun Yat-sen University

MeSH Terms

Conditions

Stomatitis; Ulcer

Interventions

Cisplatin; Radiotherapy, Intensity-Modulated; urinastatin; Injections

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Drug Administration Routes; Drug Therapy

Study Officials

• zhao chong

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 2, 2017
• First Posted: January 2, 2018
• Study Start: January 30, 2018
• Primary Completion: December 28, 2021
• Study Completion: January 31, 2024
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

CN (1)