Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer

StatusCompleted
PhasePhase 3
Started

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Record History

The 50 most recent of 502 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Apr 28, 2020, no change to tracked fieldsv501-v502
  2. Secondary endpoints: 4 to 5
    • Site details revised at 6 of 894 sites
    v500
  3. Results first posted: Feb 9, 2015v499 Show 9 more changesShow less
    • Primary endpoint revised
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 3768 to confirmed 3397
    • Study completion date: Nov 2012
    • Interventions: cetuximab (Biological), fluorouracil (Drug), irinotecan hydrochloride (Drug), leucovorin calcium (Drug), oxaliplatin (Drug) to Locally Directed Therapy (Drug), cetuximab (Biological), fluorouracil (Drug), irinotecan hydrochloride (Drug), leucovorin calcium (Drug)…
    • Eligibility criteria shortened, about 15 words
    • Secondary endpoints: 3 to 4
    • Study description shortened, about 48 words
    • Study arms: 6 to 7
  4. Primary completion date: Nov 2011 to Nov 2012v498
  5. Primary completion date changed from estimate of Jan 2100 to Nov 2011v497
Show 44 earlier versionsHide 44 earlier versions
  1. 2 versions Re-verified since Aug 16, 2012, no change to tracked fieldsv495-v496
  2. Lead sponsor: North Central Cancer Treatment Group to National Cancer Institute (NCI)v494 Show 9 more changesShow less
    • Primary completion date: Nov 2011 to Jan 2100
    • Primary endpoint revised
    • Trial status: Completed to Active, Not Recruiting
    • Study sites: 745 to 894
    • Eligibility criteria shortened, about 32 words
    • Secondary endpoints: 1 to 3
    • Study description revised
    • Collaborators: 2 to 1
    • Publications: 18 to 12
  3. Publications: 17 to 18v493
  4. Publications: details revised at 1 of 17 entriesv492
  5. Primary completion date changed from estimate of Jul 2006 to Nov 2011
    • Trial status: Active, Not Recruiting to Completed
    • Publications: 15 to 17
    v491
  6. Re-verified, no change to tracked fieldsv490
  7. Site details revised at 1 of 745 sites
    • Publications: 13 to 15
    v489
  8. Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (745)
    v488
  9. Site contacts updated at 4 of 745 sitesv487
  10. Study sites: 749 to 745v486
  11. Study sites: 748 to 749v485
  12. Study sites: 750 to 748v484
  13. Study sites: 752 to 750v483
  14. Study sites revised (752)v482
  15. Study sites: 753 to 752v481
  16. Study sites: 751 to 753v480
  17. Study sites: 750 to 751v479
  18. Study sites: 748 to 750v478
  19. Study sites: 746 to 748v477
  20. Study sites: 747 to 746v476
  21. Study sites: 749 to 747v475
  22. Study sites: 750 to 749v474
  23. Study sites: 752 to 750v473
  24. Study sites: 741 to 752v472
  25. Study sites: 740 to 741v471
  26. Study sites: 738 to 740v470
  27. Study sites: 747 to 738v469
  28. Study sites: 746 to 747v468
  29. Study sites: 745 to 746v467
  30. Study sites revised (745)v466
  31. Study sites: 741 to 745v465
  32. Study sites: 742 to 741v464
  33. Study sites: 748 to 742v463
  34. Study sites: 747 to 748v462
  35. Study sites: 746 to 747v461
  36. Study sites: 745 to 746v460
  37. Study sites: 743 to 745v459
  38. Study sites: 738 to 743v458
  39. Study sites: 737 to 738v457
  40. Study sites revised (737)v456
  41. Study sites revised (737)v455
  42. Study sites: 735 to 737v454
  43. Study sites: 736 to 735v453
  • 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.
This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It was not known at the time this study was developed which combination chemotherapy regimen is more effective after surgery in treating colon cancer. This study had several key changes, based on the results of other phase III trials. As of 6/1/2005, patients no longer received irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C and F who had not gotten to irinotecan continued on arms A and D, respectively. As of 8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm A and arm D. Patients on arm G were treated per physician discretion and followed for disease and survival status. KRAS was determined in a central laboratory and was process for all patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus on patients having wild-type KRAS tumors. All modifications were approved by the Central Institution Review Board, local Institutional Review Boards, NCI, and the NCCTG Data Safety Monitoring Board.
Trial Details
NCT Number NCT00079274
Lead Sponsor National Cancer Institute (NCI)
Collaborators: Eastern Cooperative Oncology Group
Conditions
(from sponsor)		 Adenocarcinoma of the Colon, Stage III Colon Cancer
Related terms Colonic Neoplasms
Enrollment 3,397 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov