deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03387774

Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients (UTI-RTOM-NPC)

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).

Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Conditions Oral Mucositis (Ulcerative) Due to Radiation
Interventions Cisplatin Intensity Modulated Radiation Therapy Ulinastatin
Updated 14 times since 2018 Last updated: May 13, 2025 Started: Jan 30, 2018 Primary completion: Dec 28, 2021 Completion: Jan 31, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Oral Mucositis (Ulcerative) Due to Radiation and is currently completed. Affiliated Cancer Hospital & Institute of Guangzhou Medical University leads this study, which shows 14 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2018 – ~Mar 2018 · 59 days · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshot~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~Apr 2020 · 13 months · monthly snapshot~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshot~Jan 2022 – ~Feb 2023 · 13 months · monthly snapshot~Feb 2023 – ~Jul 2024 · 17 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – ~Jun 2025 · 4 months · monthly snapshot~Jun 2025 – present · 13 months · monthly snapshot

Change History

14 versions recorded

  1. Jun 2025 — Present [monthly]

    Completed PHASE3

    Status: Unknown → Completed

  2. Feb 2025 — Jun 2025 [monthly]

    Unknown PHASE3

    Status: Active Not Recruiting → Unknown

  3. Sep 2024 — Feb 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  5. Feb 2023 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

▶ Show 9 earlier versions

  1. Jan 2022 — Feb 2023 [monthly]

    Recruiting PHASE3

  2. Sep 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  3. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  4. Apr 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  5. Mar 2019 — Apr 2020 [monthly]

    Recruiting PHASE3

  6. Jan 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

  7. Jun 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  8. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  9. Jan 2018 — Mar 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  • Fifth Affiliated Hospital, Sun Yat-Sen University
  • First People's Hospital of Foshan
  • Sun Yat-sen University
Data source: Sun Yat-sen University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations