deltatrials
Terminated PHASE2 INTERVENTIONAL 2-arm NCT02736448

177Lutethium - Peptide Receptor Radionuclide Therapy (Lu-PRRT) Plus Capecitabine Versus Lu-PRRT in FDG Positive, Gastro-entero-pancreatic Neuroendocrine Tumors (Lu-Ca-S)

177Lutethium - Peptide Receptor Radionuclide Therapy (Lu-PRRT) Plus Capecitabine Versus Lu-PRRT in FDG Positive, Gastro-entero-pancreatic Neuroendocrine Tumors: a Randomized Phase II Study.

Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Updated 11 times since 2017 Last updated: Jan 9, 2025 Started: May 31, 2016 Primary completion: Aug 31, 2019 Completion: Apr 30, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Following the publication in the Official Journal of the reclassification of the drug LUTATHERA in band H, it was decided to close the enrolment early on 30/Aug/19.

A PHASE2 clinical study on Gastro-entero-pancreatic Neuroendocrine Tumors, this trial is terminated or withdrawn. The trial is conducted by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS and has accumulated 11 data snapshots since 2016. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotRecruiting~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshotRecruiting~Mar 2019 – ~May 2020 · 14 months · monthly snapshotRecruiting~May 2020 – ~Jan 2021 · 8 months · monthly snapshotActive Not Recruiting~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshotActive Not Recruiting~Mar 2021 – ~Mar 2023 · 24 months · monthly snapshotActive Not Recruiting~Mar 2023 – ~Jul 2024 · 16 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshotUnknown~Feb 2025 – ~Apr 2025 · 59 days · monthly snapshotTerminated~Apr 2025 – present · 15 months · monthly snapshotTerminated

Change History

11 versions recorded
  1. Apr 2025 — Present [monthly]

    Terminated PHASE2

  2. Feb 2025 — Apr 2025 [monthly]

    Terminated PHASE2

    Status: UnknownTerminated

  3. Sep 2024 — Feb 2025 [monthly]

    Unknown PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE2

    Status: Unknown StatusUnknown

  5. Mar 2023 — Jul 2024 [monthly]

    Unknown Status PHASE2

    Status: Active Not RecruitingUnknown Status

Show 6 earlier versions
  1. Mar 2021 — Mar 2023 [monthly]

    Active Not Recruiting PHASE2

  2. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE2

  3. May 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  4. Mar 2019 — May 2020 [monthly]

    Recruiting PHASE2

  5. Jun 2018 — Mar 2019 [monthly]

    Recruiting PHASE2

  6. Jan 2017 — Jun 2018 [monthly]

    Recruiting PHASE2

    First recorded

May 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Data source: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

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

Study Locations