deltatrials
Completed EARLY_PHASE1 INTERVENTIONAL 1-arm NCT03196180

Topical Fluorouracil and Imiquimod in Treating Patients With High-Grade Cervical Intraepithelial Neoplasia

A Feasibility Trial of Alternating Intravaginal Application of 5-Fluorouracil and Imiquimod for Treatment of High-Grade Cervical Squamous Intraepithelial Lesions

Sponsor: National Cancer Institute (NCI)

Conditions Cervical Intraepithelial Neoplasia Grade 2/3 Cervical Squamous Cell Carcinoma In Situ Cervical Squamous Intraepithelial Neoplasia 2 High Grade Cervical Intraepithelial Neoplasia
Interventions Imiquimod Topical Fluorouracil
Updated 33 times since 2017 Last updated: Mar 20, 2025 Started: Oct 15, 2019 Primary completion: Nov 4, 2020 Completion: Aug 2, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A EARLY_PHASE1 clinical study on Cervical Intraepithelial Neoplasia Grade 2/3 and Cervical Squamous Cell Carcinoma In Situ, this trial is completed. The trial is conducted by National Cancer Institute (NCI) and has accumulated 33 data snapshots since 2019. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jul 2017 – ~Jun 2018 · 11 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Sep 2018 · 2 months · monthly snapshot~Sep 2018 – ~Dec 2018 · 3 months · monthly snapshot~Dec 2018 – ~Mar 2019 · 3 months · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Sep 2019 · 3 months · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Sep 2020 · 3 months · monthly snapshot~Sep 2020 – ~Nov 2020 · 2 months · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Mar 2022 · 9 months · monthly snapshot~Mar 2022 – ~May 2023 · 14 months · monthly snapshot~May 2023 – ~Dec 2023 · 7 months · monthly snapshot~Dec 2023 – ~Jun 2024 · 6 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~May 2025 · 7 months · monthly snapshot~May 2025 – present · 14 months · monthly snapshot

Change History

33 versions recorded

  1. May 2025 — Present [monthly]

    Completed EARLY_PHASE1

  2. Oct 2024 — May 2025 [monthly]

    Completed EARLY_PHASE1

    Status: Active Not Recruiting → Completed

  3. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting EARLY_PHASE1

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting EARLY_PHASE1

  5. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting EARLY_PHASE1

▶ Show 28 earlier versions

  1. Dec 2023 — Jun 2024 [monthly]

    Active Not Recruiting EARLY_PHASE1

  2. May 2023 — Dec 2023 [monthly]

    Active Not Recruiting EARLY_PHASE1

  3. Mar 2022 — May 2023 [monthly]

    Active Not Recruiting EARLY_PHASE1

  4. Jun 2021 — Mar 2022 [monthly]

    Active Not Recruiting EARLY_PHASE1

  5. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting EARLY_PHASE1

  6. Jan 2021 — May 2021 [monthly]

    Active Not Recruiting EARLY_PHASE1

  7. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting EARLY_PHASE1

  8. Nov 2020 — Dec 2020 [monthly]

    Active Not Recruiting EARLY_PHASE1

  9. Sep 2020 — Nov 2020 [monthly]

    Active Not Recruiting EARLY_PHASE1

    Status: Recruiting → Active Not Recruiting

  10. Jun 2020 — Sep 2020 [monthly]

    Recruiting EARLY_PHASE1

  11. May 2020 — Jun 2020 [monthly]

    Recruiting EARLY_PHASE1

  12. Apr 2020 — May 2020 [monthly]

    Recruiting EARLY_PHASE1

  13. Mar 2020 — Apr 2020 [monthly]

    Recruiting EARLY_PHASE1

  14. Feb 2020 — Mar 2020 [monthly]

    Recruiting EARLY_PHASE1

  15. Jan 2020 — Feb 2020 [monthly]

    Recruiting EARLY_PHASE1

  16. Dec 2019 — Jan 2020 [monthly]

    Recruiting EARLY_PHASE1

    Phase: PHASE1 → EARLY_PHASE1

  17. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  18. Oct 2019 — Nov 2019 [monthly]

    Not Yet Recruiting PHASE1

  19. Sep 2019 — Oct 2019 [monthly]

    Not Yet Recruiting PHASE1

  20. Jun 2019 — Sep 2019 [monthly]

    Not Yet Recruiting PHASE1

  21. May 2019 — Jun 2019 [monthly]

    Not Yet Recruiting PHASE1

  22. Apr 2019 — May 2019 [monthly]

    Not Yet Recruiting PHASE1

  23. Mar 2019 — Apr 2019 [monthly]

    Not Yet Recruiting PHASE1

  24. Dec 2018 — Mar 2019 [monthly]

    Not Yet Recruiting PHASE1

  25. Sep 2018 — Dec 2018 [monthly]

    Not Yet Recruiting PHASE1

  26. Jul 2018 — Sep 2018 [monthly]

    Not Yet Recruiting PHASE1

  27. Jun 2018 — Jul 2018 [monthly]

    Not Yet Recruiting PHASE1

  28. Jul 2017 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

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

Study Locations