Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

StatusCompleted
PhasePhase 3
Started

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Record History

The 50 most recent of 1488 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Study completion moved earlier from Apr 11, 2027 to May 26, 2026
    • Study sites: 929 to 928
    v1488
  2. Study sites revised (929)v1487
  3. Study sites: 930 to 929v1486
  4. Changed Study completion pushed from Apr 11, 2026 to Apr 11, 2027
  5. Study completion date: Apr 11, 2026 to Apr 11, 2027v1485
Show 46 earlier versionsHide 46 earlier versions
  1. Study sites: 931 to 930v1484
  2. 22 versions Re-verified since Mar 11, 2026, no change to tracked fieldsv1462-v1483
  3. Study sites revised (931)v1461
  4. 4 versions Re-verified since Mar 4, 2026, no change to tracked fieldsv1457-v1460
  5. Study sites revised (931)v1456
  6. Study sites revised (931)v1455
  7. Study sites revised (931)v1454
  8. Study sites revised (931)v1453
  9. Results first posted: Jul 20, 2025v1452 Show 8 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 2432 to 2431
    • Interventions: Bevacizumab (Biological), Fluorouracil (Drug), Laboratory Biomarker Analysis (Other), Leucovorin Calcium (Drug), Oxaliplatin (Drug) to Bevacizumab (Biological), Fluorouracil (Drug), Leucovorin (Drug), Oxaliplatin (Drug)
    • Secondary endpoints: 3 to 2
    • Study sites revised (931)
    • Eligibility criteria shortened, about 5 words
    • Study description shortened, about 4 words
    • Study title shortened, about 1 word
  10. Enrollment target: estimated 3610 to confirmed 2432
    • Primary completion date changed from estimate of Aug 31, 2025 to Feb 22, 2024
    • Study completion date: Aug 31, 2025 to Apr 11, 2026
    v1451
  11. Site details revised at 1 of 931 sitesv1450
  12. Study sites revised (931)v1449
  13. Study sites revised (931)v1448
  14. Study sites revised (931)v1447
  15. Primary and study completion dates: Feb 28, 2025 to Aug 31, 2025v1446
  16. Study sites revised (931)v1445
  17. Study sites revised (931)v1444
  18. Study sites revised (931)v1443
  19. Study sites revised (931)v1442
  20. Re-verified, no change to tracked fieldsv1441
  21. Primary and study completion dates: Dec 31, 2024 to Feb 28, 2025v1440
  22. Re-verified, no change to tracked fieldsv1439
  • 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 studies oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer.
Trial Details
NCT Number NCT00217737
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Colon Adenocarcinoma, Stage IIA Colon Cancer AJCC v7, Stage IIB Colon Cancer AJCC v7, Stage IIC Colon Cancer AJCC v7
Related terms Colonic Neoplasms
Enrollment 2,431 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov