deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01535053

Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia

A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia

Sponsor: GOG Foundation

Conditions Choriocarcinoma FIGO Stage I Gestational Trophoblastic Tumor FIGO Stage II Gestational Trophoblastic Tumor FIGO Stage III Gestational Trophoblastic Tumor Hydatidiform Mole
Interventions Dactinomycin Leucovorin Calcium Methotrexate Quality-of-Life Assessment
Updated 17 times since 2017 Last updated: Aug 10, 2022 Started: Jun 18, 2012 Primary completion: May 31, 2018 Completion: Jul 17, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Choriocarcinoma and FIGO Stage I Gestational Trophoblastic Tumor, this trial is completed. The trial is conducted by GOG Foundation and has accumulated 17 data snapshots since 2012. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Sep 2017 · 3 months · monthly snapshot~Sep 2017 – ~Jun 2018 · 9 months · monthly snapshot~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshot~Feb 2019 – ~Sep 2019 · 7 months · monthly snapshot~Sep 2019 – ~Jan 2021 · 16 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Oct 2021 · 8 months · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Sep 2022 · 9 months · monthly snapshot~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 7 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

17 versions recorded

  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Present [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Sep 2022 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 12 earlier versions

  1. Dec 2021 — Sep 2022 [monthly]

    Completed PHASE3

  2. Nov 2021 — Dec 2021 [monthly]

    Completed PHASE3

    Status: Unknown Status → Completed

  3. Oct 2021 — Nov 2021 [monthly]

    Unknown Status PHASE3

    Status: Active Not Recruiting → Unknown Status

  4. Feb 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE3

  5. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE3

  6. Sep 2019 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  7. Feb 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE3

  8. Jun 2018 — Feb 2019 [monthly]

    Active Not Recruiting PHASE3

  9. Sep 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  10. Jun 2017 — Sep 2017 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  11. Feb 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  12. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Jun 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

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

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

Study Locations

Aberdeen, United States , Abington, United States , Akron, United States , Albuquerque, United States , Anaconda, United States , Anacortes, United States , Anchorage, United States , Atlanta, United States , Augusta, United States , Aurora, United States and 187 more locations