Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

The 50 most recent of 60 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Dec 2025 to Dec 2026v60
  2. Primary and study completion dates: Dec 2024 to Dec 2025v59
  3. Re-verified, no change to tracked fieldsv58
  4. Primary and study completion dates: Dec 2023 to Dec 2024v57
  5. Primary and study completion dates: Dec 2022 to Dec 2023v56
Show 45 earlier versionsHide 45 earlier versions
  1. Primary and study completion dates: Dec 2021 to Dec 2022v55
  2. Primary and study completion dates: Dec 2020 to Dec 2021v54
  3. 2 versions Re-verified since Oct 7, 2019, no change to tracked fieldsv52-v53
  4. Primary and study completion dates: Dec 2019 to Dec 2020v51
  5. Primary and study completion dates: Dec 2018 to Dec 2019v50
  6. Primary completion date: Dec 2017 to Dec 2018
    • Study completion date: Dec 2018
    v49
  7. 7 versions Re-verified since Jun 10, 2013, no change to tracked fieldsv42-v48
  8. Lead sponsor: City of Hope Medical Center to Memorial Sloan Kettering Cancer Centerv41
  9. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 15 of 15 sites
    v40
  10. Interventions: conventional surgery (Procedure), fluorouracil (Drug), leucovorin calcium (Drug), oxaliplatin (Drug), radiation therapy (Radiation) to DNA analysis (Genetic), conventional surgery (Procedure), fluorouracil (Drug), immunohistochemistry staining method (Other), laboratory…
    • Eligibility criteria expanded, about 228 words
    • Study description shortened, about 65 words
    v39
  11. Study sites revised (15)v38
  12. Re-verified, no change to tracked fieldsv37
  13. Site details revised at 1 of 15 sitesv36
  14. Primary completion date: Dec 2010 to Dec 2017
    • Start date: Aug 2003 to Aug 2008
    v35
  15. Lead sponsor: Beckman Research Institute to City of Hope Medical Center
    • Primary completion date: Jun 2009 to Dec 2010
    • Primary endpoints: 2 to 3
    • Site contacts updated at 1 of 15 sites
    v34
  16. 2 versions Re-verified since Jun 27, 2009, no change to tracked fieldsv32-v33
  17. Lead sponsor: University of California, San Francisco to Beckman Research Institute
    • Study sites: 13 to 15
    v31
  18. Interventions: conventional surgery (Procedure), fluorouracil (Drug), leucovorin calcium (Drug), oxaliplatin (Drug), radiation therapy (Procedure) to conventional surgery (Procedure), fluorouracil (Drug), leucovorin calcium (Drug), oxaliplatin (Drug), radiation therapy (Radiation)v30
  19. Re-verified, no change to tracked fieldsv29
  20. Site contacts updated at 1 of 13 sitesv28
  21. 2 versions Re-verified since Jul 23, 2008, no change to tracked fieldsv26-v27
  22. Interventions: conventional surgery (Procedure), fluorouracil (Drug), leucovorin calcium (Drug), neoadjuvant therapy (Procedure), oxaliplatin (Drug)… to conventional surgery (Procedure), fluorouracil (Drug), leucovorin calcium (Drug), oxaliplatin (Drug), radiation therapy (Procedure)
    • Study arms: 0 to 4
    v25
  23. Re-verified, no change to tracked fieldsv24
  24. Interventions: chemotherapy (Procedure), conventional surgery (Procedure), fluorouracil (Drug), leucovorin calcium (Drug), neoadjuvant therapy… to conventional surgery (Procedure), fluorouracil (Drug), leucovorin calcium (Drug), neoadjuvant therapy (Procedure), oxaliplatin (Drug)…v23
  25. Site contacts updated at 2 of 13 sitesv22
  26. Study sites revised (13)v21
  27. Re-verified, no change to tracked fieldsv20
  28. Study sites revised (13)v19
  29. Site contacts updated at 1 of 13 sitesv18
  30. Primary completion date: Jun 2009v17
  31. Study sites revised (13)v16
  32. Study sites revised (13)v15
  33. Study sites revised (13)v14
  34. Interventions: Intervention/procedure (Procedure), chemotherapy (Procedure), conventional surgery (Procedure), fluorouracil (Drug), leucovorin calcium… to chemotherapy (Procedure), conventional surgery (Procedure), fluorouracil (Drug), leucovorin calcium (Drug), neoadjuvant therapy…v13
  35. Interventions: chemotherapy (Procedure), conventional surgery (Procedure), fluorouracil (Drug), leucovorin calcium (Drug), neoadjuvant therapy… to Intervention/procedure (Procedure), chemotherapy (Procedure), conventional surgery (Procedure), fluorouracil (Drug), leucovorin calcium…v12
  36. Study sites revised (13)v11
  • 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.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Fluorouracil may also make tumor cells more sensitive to radiation therapy. Leucovorin calcium may protect normal cells from the side effects of chemotherapy, and it may help fluorouracil work better by making tumor cells more sensitive to the drug. Giving radiation therapy together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving radiation therapy together with fluorouracil with or without combination therapy works in treating patients who are undergoing surgery for stage II or stage III rectal cancer.
Trial Details
NCT Number NCT00335816
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Colorectal Cancer
Related terms Colorectal Neoplasms, Rectal Neoplasms
Enrollment 248 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov