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NCT00046995 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy in Treating Patients With Colon Cancer

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
UNKNOWN
Registry last update
2013-09-20

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which schedule of chemotherapy is most effective in treating colon cancer. PURPOSE: Randomized phase III trial to compare different schedules of chemotherapy using carboplatin with fluorouracil and leucovorin in treating patients who have stage IIB or stage III colon cancer.

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: * Histologically confirmed adenocarcinoma of the colon * Stage IIB or III (Dukes stage B2 or C) * Complete curative resection performed within the past 7 weeks (negative margins) * No local or regional relapsed disease * Tumor more than 15 cm above the anal margin * Carcinoembryonic antigen less than 5 ng/mL (after surgery) * No rectal cancer * No metastatic disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 OR * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Neutrophil count at least 2,000/mm3 * Platelet count at least 100,000/mm3 Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT and SGPT no greater than 5 times ULN Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * No serious coronary disease Other * Not pregnant * Fertile patients must use effective contraception * No concurrent infectious disease * No other malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy (before or after surgery) Surgery * See Disease Characteristics Other * No concurrent participation in another clinical trial
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    carboplatin
    type
    DRUG
  2. name
    fluorouracil
    type
    DRUG
  3. name
    leucovorin calcium
    type
    DRUG
  4. name
    adjuvant therapy
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
Enrollment
count
800
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Disease-free survival
secondary Outcomes
  1. measure
    Tolerability
  2. measure
    Quality of life
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. It is not yet known which schedule of chemotherapy is most effective in treating colon cancer. PURPOSE: Randomized phase III trial to compare different schedules of chemotherapy using carboplatin with fluorouracil and leucovorin in treating patients who have stage IIB or stage III colon cancer.
detailed Description
OBJECTIVES: * Compare the disease-free survival of patients with completely resected stage IIB or III colon cancer treated with adjuvant chronomodulated vs standard schedule fluorouracil and leucovorin calcium with or without carboplatin. * Compare the overall survival of patients treated with these regimens. * Compare the toxicity of these regimens in these patients. * Compare the quality of life of patients treated with these regimens. * Determine the dose intensities of fluorouracil and carboplatin in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and disease stage (IIB vs III). Patients are randomized to 1 of 4 treatment arms. * Arm I (standard schedule): Patients receive fluorouracil (5-FU) IV continuously and leucovorin calcium (CF) IV on days 1 and 2. * Arm II (standard + carboplatin schedule): Patients receive 5-FU and CF as in arm I plus carboplatin IV on day 1. * Arm III (chronomodulated schedule): Patients receive 5-FU IV continuously and CF IV continuously on days 1-4. * Arm IV (chronomodulated + carboplatin schedule): Patients receive 5-FU and CF as in arm III plus carboplatin IV continuously on days 1-4. Quality of life is assessed. Treatment in all arms repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 660-800 patients will be accrued for this study.
Source references
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        > <p id="_704" tabindex="-1">Evidence (adjuvant chemotherapy):</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 chemothe
        end
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      2. context exact
        dex="-1">Evidence (adjuvant chemotherapy):</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.
        end
        131112
        exact text
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        start
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      source record id
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      source retrieved at
      2026-09-09T23:21:38.940003+00:00
      source string basis
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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