Edrecolomab in Treating Patients With Stage II Colon Cancer

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv25
  2. Publications shortened, about 75 wordsv24
  3. Re-verified, no change to tracked fieldsv23
  4. Primary completion date: Mar 2010 to Jul 2003v22
  5. Primary completion date: Jul 2003 to Mar 2010v21 Show 10 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 1738 to 2100
    • Study sites: 32 to 1
    • Study completion date: Jun 2010 to not stated
    • Interventions: edrecolomab (Biological) to edrecolomab (Biological), laboratory biomarker analysis (Other)
    • Eligibility criteria expanded, about 108 words
    • Secondary endpoints: 1 to 2
    • Study description expanded, about 13 words
    • Collaborators shortened, about 27 words
    • Study title shortened, about 9 words
Show 19 earlier versionsHide 19 earlier versions
  1. Lead sponsor: Cancer and Leukemia Group B to National Cancer Institute (NCI)
    • Collaborators: 6 to 5
    v20
  2. Primary completion date: Jan 2008 to Jul 2003v19
  3. Primary completion date: Mar 2010 to Jan 2008v18 Show 5 more changesShow less
    • Primary endpoint revised
    • Enrollment target: estimated 2100 to confirmed 1738
    • Study completion date: Jun 2010
    • Secondary endpoints: 2 to 1
    • Study arms: 0 to 2
  4. Trial status: Active, Not Recruiting to Completed
    • Primary completion date: Mar 2010
    • Collaborators revised (6)
    v17
  5. Publications: 1 to 2v16
  6. Interventions: edrecolomab (Drug) to edrecolomab (Biological)v15
  7. Re-verified, no change to tracked fieldsv14
  8. Interventions: edrecolomab (Drug), monoclonal antibody therapy (Procedure) to edrecolomab (Drug)v13
  9. Re-verified, no change to tracked fieldsv12
  10. Start date: May 1997v11
  11. Publication revisedv10
  12. Interventions: antibody therapy (Procedure), biological therapy (Procedure), edrecolomab (Drug), monoclonal antibody therapy (Procedure) to edrecolomab (Drug), monoclonal antibody therapy (Procedure)
    • Publication revised
    v9
  13. Publication revisedv8
  14. Publication revisedv7
  15. Study Status, Outcome Measuresv6
  16. 2 versions Re-verified since Mar 5, 2007, no change to tracked fieldsv4-v5
  17. Enrollment target: 2100
    • Interventions: antibody therapy (Procedure), biological response modifier therapy (Procedure), edrecolomab (Drug), monoclonal antibody therapy (Procedure) to antibody therapy (Procedure), biological therapy (Procedure), edrecolomab (Drug), monoclonal antibody therapy (Procedure)
    • Collaborators revised (6)
    v3
  18. Site details revised at 1 of 32 sitesv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Randomized phase III trial to compare the effectiveness of surgery with or without monoclonal antibody therapy in treating patients who have stage II colon cancer. Monoclonal antibodies such as edrecolomab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether surgery to remove colon cancer is more effect with or without monoclonal antibody therapy.
Trial Details
NCT Number NCT00002968
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Mucinous Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Colon, Stage IIA Colon Cancer, Stage IIB Colon Cancer, Stage IIC Colon Cancer
Related terms Colonic Neoplasms
Enrollment 2,100 participants
Start Date
Primary Completion (estimated)
Updated on ClinicalTrials.gov