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Edrecolomab in Treating Patients With Stage II Colon Cancer

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status, References

    Re-verified, no change to tracked fields

    v25

  2. Minor

    Publications shortened, about 75 words

    Show what changed: Publications
    Bertagnolli MM, Niedzwiecki D, Hall M, et al.: Presence of 18q loss of heterozygosity (LOH) and disease-free and overall survival in stage II colon cancer: CALGB Protocol 9581. [Abstract] J Clin Oncol 27 (Suppl 15): A-4012, 2009. Colacchio TA, Niedzwiecki D, Compton C, et al.: Phase III trial of adj [...]

    Study Status, Referencesv24

  3. Minor

    Study Identification, Study Status, Study Description

    Re-verified, no change to tracked fields

    v23

  4. Notable

    Primary completion date: Mar 2010 to Jul 2003

    Study Statusv22

  5. Notable

    Primary completion date: Jul 2003 to Mar 2010

    Primary endpoint revised; Enrollment target: 1738 to 2100; Study sites: 32 to 1; and 7 more

    Show all 11 changes in this update
    • Notable Primary completion date: Jul 2003 to Mar 2010
    • Notable Primary endpoint revised
      Show what changed
      Overall Survival
    • Minor Enrollment target: 1738 to 2100
    • Minor Study sites: 32 to 1
    • Minor Completion date: Jun 2010 to not stated
    • Minor Interventions: edrecolomab (Biological) to edrecolomab (Biological), laboratory biomarker analysis (Other)
    • Minor Eligibility criteria expanded, about 108 words
      Show what changed
      DISEASEInclusion CHARACTERISTICSCriteria: HistologicallyPathologic provendocumentation of adenocarcinoma of the colon (Stage II pT3, N0 or pT4b, N0, excluding pT4a, N0) Withwith or without penetration of the serosa No with no lymph node metastases No (Stage II pT3N0 or pT4bNO lesions, excluding pT4aN0; Modified Astler-Coller Stage B2); there can be no distant metastases or penetration of adjacent organs or structures/organs Proximal; proximal, distal, and radial margins must be free of tumor free Important note: A tumor nodule > 3 mm in diameter in the perirectal or pericolonic adipose tissue [...] [...]
    • Minor Secondary endpoints: 1 to 2
      Show what changed
      Disease-free intervals Disease-free survival
    • Minor Study description expanded, about 13 words
      Show what changed
      PRIMARY OBJECTIVES: DetermineI. To determine whether adjuvant therapytreatment with edrecolomabMoAb improves17-1A will improve the probability of survivaloverall and disease-free survival, and increasesincrease disease-free intervals in patients who have undergone resection forof stagea Stage II colon cancer. DetermineII. To determine whether alterations in the expression of cell cycle related genes predict(thymidylate thesynthase, risk of survival or recurrence in this patient population. Determine whether alterations in markers of metastatic potential such as expression of the "Deleted in Co [...] [...]
    • Minor Collaborators shortened, about 27 words
      Show what changed
      SWOG Cancer Research Network Eastern Cooperative Oncology Group North Central Cancer Treatment Group European Organisation for Research and Treatment of Cancer - EORTC NCIC Clinical Trials Group
    • Minor Study title shortened, about 9 words
      Show what changed
      Monoclonal Antibody Therapy Compared With No Further Therapy After SurgeryEdrecolomab in Treating Patients With Stage II Colon Cancer

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, Referencesv21

Show 19 earlier versions

  1. Notable

    Lead sponsor: Cancer and Leukemia Group B to National Cancer Institute (NCI)

    Collaborators: 6 to 5

    Show what changed: Collaborators
    National Cancer Institute (NCI)

    Study Identification, Study Status, Sponsor/Collaboratorsv20

  2. Notable

    Primary completion date: Jan 2008 to Jul 2003

    Study Status, Outcome Measuresv19

  3. Notable

    Primary completion date: Mar 2010 to Jan 2008

    Primary endpoint revised; Enrollment target: estimated 2100 to confirmed 1738; Completion date: Jun 2010; and 2 more

    Show all 6 changes in this update
    • Notable Primary completion date: Mar 2010 to Jan 2008
    • Notable Primary endpoint revised
      Show what changed
      ProbabilityOverall of survivalSurvival
    • Minor Enrollment target: estimated 2100 to confirmed 1738
    • Minor Completion date: Jun 2010
    • Minor Secondary endpoints: 2 to 1
      Show what changed
      Disease-free intervals Disease-free survival
    • Minor Study arms: 0 to 2

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Outcome Measuresv18

  4. Minor

    Trial status: Active, Not Recruiting to Completed

    Primary completion date: Mar 2010; Collaborators revised (6)

    Show what changed: Collaborators
    CanadianNCIC CancerClinical Trials Group

    Study Status, Sponsor/Collaboratorsv17

  5. Minor

    Publications: 1 to 2

    Show what changed: Publications
    Bertagnolli MM, Niedzwiecki D, Hall M, et al.: Presence of 18q loss of heterozygosity (LOH) and disease-free and overall survival in stage II colon cancer: CALGB Protocol 9581. [Abstract] J Clin Oncol 27 (Suppl 15): A-4012, 2009.

    Study Status, Referencesv16

  6. Minor

    Interventions: edrecolomab (Drug) to edrecolomab (Biological)

    Study Status, Arms and Interventionsv15

  7. Minor

    Study Status, Study Design

    Re-verified, no change to tracked fields

    v14

  8. Minor

    Interventions: edrecolomab (Drug), monoclonal antibody therapy (Procedure) to edrecolomab (Drug)

    Study Status, Arms and Interventionsv13

  9. Minor

    Study Status

    Re-verified, no change to tracked fields

    v12

  10. Minor

    Start date: May 1997

    Study Statusv11

  11. Minor

    Publication revised

    Show what changed: Publications
    UnableColacchio to connect to PubMed to validate TA, lastNiedzwiecki attempt on October 26D, 2007Compton atC, 6et al.: Phase III trial of adjuvant immunotherapy with MOAb 17-1A AMfollowing EDTresection for stage II adenocarcinoma of the colon (CALGB 9581). [Abstract] J Clin Oncol 22 (Suppl 14): A-3522, 250s, 2004.

    Study Status, Contacts/Locations, Referencesv10

  12. Minor

    Interventions: antibody therapy (Procedure), biological therapy (Procedure), edrecolomab (Drug), monoclonal antibody therapy (Procedure) to edrecolomab (Drug), monoclonal antibody therapy (Procedure)

    Publication revised

    Show what changed: Publications
    ColacchioUnable TAto connect to PubMed to validate , Niedzwieckilast Dattempt on October 26, Compton2007 C,at et6:17 al.:AM Phase III trial of adjuvant immunotherapy with MOAb 17-1A following resection for stage II adenocarcinoma of the colon (CALGB 9581). [Abstract] J Clin Oncol 22 (Suppl 14): A-3522, 250s, 2004.EDT

    Study Status, Arms and Interventions, Referencesv9

  13. Minor

    Publication revised

    Show what changed: Publications
    UnableColacchio to connect to PubMed to validate nullTA, lastNiedzwiecki attempt on July 27D, 2007Compton atC, 3et al.:37 PMPhase EDTIII trial of adjuvant immunotherapy with MOAb 17-1A following resection for stage II adenocarcinoma of the colon (CALGB 9581). [Abstract] J Clin Oncol 22 (Suppl 14): A-3522, 250s, 2004.

    Study Status, Referencesv8

  14. Minor

    Publication revised

    Show what changed: Publications
    ColacchioUnable TAto connect to PubMed to validate null, Niedzwieckilast Dattempt on July 27, Compton2007 C,at et3:37 al.:PM Phase III trial of adjuvant immunotherapy with MOAb 17-1A following resection for stage II adenocarcinoma of the colon (CALGB 9581). [Abstract] J Clin Oncol 22 (Suppl 14): A-3522, 250s, 2004.EDT

    Study Status, Referencesv7

  15. Minor

    Study Status, Outcome Measures

    v6

  16. Minor

    2 amendments

    2 re-verifications since 2007-03-05, no change to tracked fields

    v4-v5

  17. Minor

    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)

    Show what changed: Collaborators
    EORTCEuropean GastrointestinalOrganisation Tractfor Research and Treatment of Cancer Cooperative- GroupEORTC

    Study Identification, Study Status, Sponsor/Collaborators, Conditions, Study Design, Arms and Interventions, Eligibility, Contacts/Locations, Referencesv3

  18. Minor

    Site details revised at 1 of 32 sites

    Study Status, Contacts/Locationsv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 Mucinous Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Colon, Stage IIA Colon Cancer, Stage IIB Colon Cancer, Stage IIC Colon Cancer
Enrollment 2,100 participants
Start Date
Primary Completion (estimated)
Updated on ClinicalTrials.gov