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Oral Mucositis (Ulcerative) Due to RadiationPhase 3UTI-RTOM-NPCNCT03387774

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

A Phase 3 study testing Cisplatin, Intensity Modulated Radiation Therapy and Ulinastatin in people with Oral Mucositis (Ulcerative) Due to Radiation, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Cisplatin, Intensity Modulated Radiation Therapy and Ulinastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
1 siteChina
Study dates
30 Jan 2018to 31 Jan 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Center, Sun Yat-sen University

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: A Phase 3, Open Label, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy of Ulinastatin in the Reduction of Acute Oral Mucositis Caused by Concurrent Chemoradiotherapy(CCRT) for Patients With Localregionally Advanced Nasopharyngeal Carcinoma (NPC).

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.

Read the detailed description

Radiation-induced acute oral mucositis (RTOM) in Nasopharyngeal Carcinoma (NPC) patients treat with concurrent chemoradiotherapy (CCRT) is common. Currently, there is no effective treatment for RTOM. Ulinastatin, is a kind of natural anti-inflammatory substance. And this substance is insufficient when the body's inflammatory response is strongly. There are a series of studies have confirmed the efficacy and safety of ulinastatin in the treatment of body's inflammatory response. From the observation of our previous clinical practice, we found that ulinastatin can relieve the severity of RTOM. The present study is undertaken to evaluate the efficacy of ulinastatin in the treatment of RTOM in localregionally advanced NPC patients treated with CCRT.

Being tested
Cisplatin, Intensity Modulated Radiation Therapy, Ulinastatin
Keywords
Ulinastatin, Radiation-induced acute oral mucositis, Localregionally Advanced Nasopharyngeal Carcinoma, Intensity Modulated Radiation Therapy
Medical subject headings
Stomatitis, Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called DDP

    Patients in both arms received concurrent cisplatin chemotherapy:

    100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.

  • Intensity Modulated Radiation TherapyRadiation

    Also called IMRT

    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).

  • UlinastatinDrug

    Also called UTI for injection

    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.

Study groups in NCT03387774
Study groupRoleWhat they receive
Concurrent chemoradiotherapy and ulinastatinExperimentalConcurrent 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.
Receives: Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy; Drug: Ulinastatin
Concurrent chemoradiotherapyActive comparatorConcurrent chemoradiotherapy (CCRT) alone: Intensity modulated radiation therapy combined with concurrent chemotherapy of cisplatin 100mg/m2 on day 1 and day 22 of RT.
Receives: Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 19 weeks

Secondary outcomes (9)

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

    Weeks to onset is the duration from the start of radiotherapy to the week of first severe oral mucositis occurred. Severe oral mucositis was defined as a Grade 3 or above of Common Terminology Criteria For Adverse Events of Version 4.03 (CTCAE 4.03). 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 weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks, and assessed once at 1 month after CCRT and 3 months after CCRT, respectively. Time to onset of severe mucositis will be recorded. The whole observation time may up to 19 weeks.

    Measured: Up to Week 19

  2. Oral Assessment Guide (OAG) Score

    The Oral Assessment Guide (OAG) score is calculated based on the following categories: ability of swallow; the appearance of lips; the appearance of tongue; the appearance of oral mucous membranes; the appearance of gingivae; the appearance of teeth; and the change of voice. There are three grades in every category. The details about Oral Assessment Guide is available in: http://www.rch.org.au/rchcpg/hospital_clinical_guideline_index/Mouth_Care_of_the_paediatric_oncology_patient/. The OAG score will be assessed weekly 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.

    Measured: Up to 19 weeks

  3. Oral Mucositis Scores by World Health Organization (WHO)

    The Oral Mucositis Score of World Health Organization (WHO) was classified based on the changes of patients' oral mucosa and ability to eat, and are classified to 4 grades. WHO scale for oral mucositis (available in: Peterson DE, Boersdoets CB, Bensadoun RJ, et al. Management of oral and gastrointestinal mucosal injury: ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up. Annals of Oncology 2015; 26(supply5). https://doi.org/10.1093/annonc/mdv202): Grade 0 = no oral mucositis; Grade 1 = erythema and soreness; Grade 2 = ulcers, able to eat solids; Grade 3 = ulcers, requires liquid diet (due to mucositis); Grade 4 = ulcers, alimentation not possible (due to mucositis). The WHO score will be assessed weekly 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.

    Measured: Up to 19 weeks

  4. Rate of Participants With Unplanned Breaks in Radiotherapy

    Participants with a duration of 5 days or more without an administration of radiotherapy or who discontinue radiotherapy prior to completion of planned radiotherapy were considered to have an unplanned break in radiotherapy. The rate of unplanned break was calculated for both arms.

    Measured: During the 7 weeks for concurrent chemoradiotherapy

  5. Quality of Life with EORTC QLQ-C30

    The quality of life for all participants was evaluated according to The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (available in: Grønvold M. EORTC QLQ-C30 Scoring Manual 2014.). The EORTC QLQ-C30 shoule be completed weekly 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.

    Measured: Up to 19 weeks

  6. Karnofsky Performance Status Scale

    The functional status for all participants was assessed according to Karnofsky Performance Status Scale (KPS Scale) (available in: Friendlander AH, Ettinger RL. Karnofsky performance status scale[J]. Special Care in Dentistry, 2009, 29(4):147.). The KPS Scale was range from 0 to 100, and were averagely divided into eleven grades begin with 0. The KPS Scale will be recoreded weekly 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.

    Measured: Up to 19 weeks

  7. Numeric Rating Scale for Pain(NRS scale)

    The pain caused by oral mucositis for all participants was assessed according to Numeric Rating Scale (NRS scale), by which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. And an 11-point scale where 0 indicates no pain and 10 indicates the worst imaginable pain. The scale for each patient was recorded. The NRS scale will be assessed weekly 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.

    Measured: Up to 19 weeks

  8. 3 Months Overall Response Rate

    Efficacy was estimated according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST 1.1) (available in: Watanabe H, Okada M, Kaji Y, et al. New response evaluation criteria in solid tumours-revised RECIST guideline (version 1.1. European Journal of Cancer, 2009, 45(2):228-247.). The efficacy was divided into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). And CR was defined as disappearance of all target lesions, PR was defined as at least a 30% reduction in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the sum rate of patients with CR and PR for the total number of evaluable patients.

    Measured: Assessed at 3 months after concurrent chemoradiotherapy

  9. The Adverse events Related to Ulinastatin

    The adverse events related to ulinastatin based on medicine specification of ulinastatin was observed and recorded down according to Common toxicity criteria, version 2.0. (available in: Version CTC, Version CTC, Date P, et al. Common toxicity criteria (ctc) 1999.).

    Measured: Up to 19 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2018
  2. Study start30 Jan 2018
  3. Primary completion28 Dec 2021
  4. Study completion31 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03387774
Sponsor's protocol ID
UTI-RTOM-NPC
Acronym
UTI-RTOM-NPC
Status last verified
May 2026
First submitted
2 Dec 2017
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin, Intensity Modulated Radiation Therapy and Ulinastatin in people with Oral Mucositis (Ulcerative) Due to Radiation, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Severe Acute Oral Mucositis (Grade of CTC-AE ≥ 3) (time frame: Up to 19 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03387774.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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