deltatrials
Unknown PHASE3 INTERVENTIONAL NCT00091312

Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

Randomized Phase III Intergroup Trial in Resected Stage 2 (Dukes B) Colon Cancer: 6-Month Infusional 5FU-CPT11 (+/- Folinic Acid) Versus Observation - Determination of Biologic Predictive and Response Factors

Sponsor: Federation Francophone de Cancerologie Digestive

Updated 6 times since 2017 Last updated: Feb 6, 2009 Started: Jun 30, 2004
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 Colorectal Cancer, this trial is ongoing. The trial is conducted by Federation Francophone de Cancerologie Digestive and has accumulated 6 data snapshots since 2004. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 9 months · monthly snapshotUnknown

Change History

6 versions recorded
  1. Sep 2025 — Present [monthly]

    Unknown PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Unknown PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE3

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status PHASE3

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Unknown Status PHASE3

    First recorded

Jun 2004

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Federation Francophone de Cancerologie Digestive
Data source: National Cancer Institute (NCI)

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