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NCT00005586 · CITED IN SOURCE DOCUMENTS

Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2013-12-18

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether chemotherapy is more effective than observation in patients who have had surgery to remove colorectal cancer. PURPOSE: This randomized phase III trial is studying leucovorin and fluorouracil to see how well they work compared to observation in treating patients with colorectal cancer that has been surgically removed.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Completely resected stage II or III colorectal cancer * No distant metastases * No positive resection margins * No positive peritoneal washings PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No clear definite indication for, or contraindication against, systemic chemotherapy with L-leucovorin and fluorouracil PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No concurrent chemotherapy in observation only arm Endocrine therapy: * Not specified Radiotherapy: * Concurrent radiotherapy allowed in adjuvant chemotherapy arm provided chemotherapy administered on the once weekly schedule Surgery: * See Disease Characteristics
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    L-leucovorin
    type
    DRUG
  2. name
    fluorouracil
    type
    DRUG
  3. name
    adjuvant therapy
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2500
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    All-cause mortality
secondary Outcomes
  1. measure
    Death from colorectal cancer
  2. measure
    Disease recurrence
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether chemotherapy is more effective than observation in patients who have had surgery to remove colorectal cancer. PURPOSE: This randomized phase III trial is studying leucovorin and fluorouracil to see how well they work compared to observation in treating patients with colorectal cancer that has been surgically removed.
detailed Description
OBJECTIVES: * Compare all-cause mortality in patients with resected colorectal cancer treated with adjuvant chemotherapy with L-leucovorin and fluorouracil vs observation. * Compare the recurrence rates in patients treated with this regimen vs observation. * Compare the effectiveness of a monthly 5-day schedule vs a once weekly schedule of L-leucovorin and fluorouracil in this patient population. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to receive adjuvant chemotherapy (arm I) or undergo observation only (arm II). * Arm I: Within 12 weeks of surgery, patients receive L-leucovorin IV followed by fluorouracil IV on days 1-5 every 4 weeks for 6 courses. Alternatively, patients may receive L-leucovorin IV followed by fluorouracil IV on day 1 weekly for 30 weeks. * Arm II: Patients undergo observation. Patients are followed annually. PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per arm) will be accrued for this study.
Source references
references
  1. citation
    Quasar Collaborative Group; Gray R, Barnwell J, McConkey C, Hills RK, Williams NS, Kerr DJ. Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet. 2007 Dec 15;370(9604):2020-9. doi: 10.1016/S0140-6736(07)61866-2.
    pmid
    18083404
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        </p> <div class="pdq-content-list"><ol id="_705"><li>The <a href="/clinicaltrials/NCT00046995">GRECCR-03</a> (NCT00046995) and <a href="/clinicaltrials/NCT00005586">NCRI-QUASAR1</a> (NCT00005586) trials evaluated the use of systemic or regional chemotherapy or biological therapy. Following surgery, patients can be conside
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        ntent-list"><ol id="_705"><li>The <a href="/clinicaltrials/NCT00046995">GRECCR-03</a> (NCT00046995) and <a href="/clinicaltrials/NCT00005586">NCRI-QUASAR1</a> (NCT00005586) trials evaluated the use of systemic or regional chemotherapy or biological therapy. Following surgery, patients can be considered for entry into a carefully
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      source retrieved at
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      source string sha256
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      source title
      Colon Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 12, 2025
        datetime
        2025-02-12T12:00:00Z
        display
        February 12, 2025

    Preserved source evidence · Not medical advice