deltatrials
Completed OBSERVATIONAL NCT00898846

Identifying Prognostic Factors in Patients Receiving Tegafur-Uracil for Stage II Colon Cancer That Was Completely Removed By Surgery

Identification of the Prognostic Factors of Stage II Colon Cancer Patients Receiving Adjuvant Chemotherapy With UFT

Sponsor: Tokyo Medical and Dental University

Updated 12 times since 2017 Last updated: Sep 26, 2016 Started: Oct 31, 2006 Primary completion: Oct 31, 2015 Completion: Sep 30, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Colorectal Cancer, this trial is completed. The trial is conducted by Tokyo Medical and Dental University and has accumulated 12 data snapshots since 2006. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

OBJECTIVES: * Identify the prognostic factors in patients with curatively resected stage II colon cancer receiving adjuvant chemotherapy with tegafur-uracil. * Identify predictive factors of chemosensitivity to this regimen in these patients. OUTLINE: Available tumor tissue samples are analyzed by real-time reverse transcriptase-PCR for TS, DPD, TP, OPRT, VEGF, cyclooxygenase-2, and FPGS; by PCR for microsatellite instability and genomic deletions on chromosome arm 18q; and pathologically for tumor budding, Crohn's-like lymphoid reaction, category of extent of poor differentiation, and fibrotic cancer stroma. The candidate prognostic and predictive markers are analyzed for correlation with disease-free survival, relapse-free survival, and overall survival of patients.

OBJECTIVES:

* Identify the prognostic factors in patients with curatively resected stage II colon cancer receiving adjuvant chemotherapy with tegafur-uracil. * Identify predictive factors of chemosensitivity to this regimen in these patients.

OUTLINE: Available tumor tissue samples are analyzed by real-time reverse transcriptase-PCR for TS, DPD, TP, OPRT, VEGF, cyclooxygenase-2, and FPGS; by PCR for microsatellite instability and genomic deletions on chromosome arm 18q; and pathologically for tumor budding, Crohn's-like lymphoid reaction, category of extent of poor differentiation, and fibrotic cancer stroma. The candidate prognostic and predictive markers are analyzed for correlation with disease-free survival, relapse-free survival, and overall survival of patients.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshotCompleted~Aug 2017 – ~Apr 2018 · 8 months · monthly snapshotCompleted~Apr 2018 – ~May 2018 · 30 days · monthly snapshotCompleted~May 2018 – ~Jun 2018 · 31 days · monthly snapshotCompleted~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotCompleted~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

12 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed

  2. Sep 2025 — Present [monthly]

    Completed

  3. Sep 2024 — Sep 2025 [monthly]

    Completed

  4. Jul 2024 — Sep 2024 [monthly]

    Completed

  5. Dec 2021 — Jul 2024 [monthly]

    Completed

Show 7 earlier versions
  1. Jan 2021 — Dec 2021 [monthly]

    Completed

  2. Nov 2020 — Jan 2021 [monthly]

    Completed

  3. Jun 2018 — Nov 2020 [monthly]

    Completed

  4. May 2018 — Jun 2018 [monthly]

    Completed

  5. Apr 2018 — May 2018 [monthly]

    Completed

    Phase: NANone

  6. Aug 2017 — Apr 2018 [monthly]

    Completed NA

  7. Jan 2017 — Aug 2017 [monthly]

    Completed NA

    First recorded

Oct 2006

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Tokyo Medical and Dental University
  • Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Data source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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