{
  "@type": "dcat:Dataset",
  "accessLevel": "public",
  "bureauCode": [
    "009:25"
  ],
  "contactPoint": {
    "@type": "vcard:Contact",
    "fn": "NIH",
    "hasEmail": "mailto:info@nih.gov"
  },
  "description": "Background\n          5-fluorouracil remains the standard therapy for patients with advanced/metastatic colorectal cancer. Pre-clinical studies have demonstrated the biological modulation of 5-fluorouracil by methotrexate and leucovorin. This phase II study was initiated to determine the activity and toxicity of sequential methotrexate – leucovorin and 5-fluorouracil chemotherapy in patients with advanced colorectal cancer.\n        \n        \n          Methods\n          Ninety-seven patients with metastatic colorectal cancer were enrolled onto the study. Methotrexate – 30 mg/m2 was administered every 6 hours for 6 doses followed by a 2 hour infusion of LV – 500 mg/m2. Midway through the leucovorin infusion, patients received 5-fluorouracil – 600 mg/m2. This constituted a cycle of therapy and was repeated every 2 weeks until progression.\n        \n        \n          Results\n          The median age was 64 yrs (34–84) and the Eastern Cooperative Group Oncology performance score was 0 in 37%, 1 in 55% and 2 in 8% of patients. Partial and complete responses were seen in 31% of patients with a median duration of response of 6.4 months. The overall median survival was 13.0 months. The estimated 1-year survival was 53.7%. Grade III and IV toxic effects were modest and included mucositis, nausea and vomiting.\n          \n            Conclusions\n            This phase II study supports previously reported data demonstrating the modest clinical benefit of 5-FU modulation utilizing methotrexate and leucovorin in patients with metastatic colorectal cancer. Ongoing studies evaluating 5-fluorouracil modulation with more novel agents (Irinotecan and/or oxaliplatin) are in progress and may prove encouraging.",
  "distribution": [
    {
      "@type": "dcat:Distribution",
      "description": "Visit the original government dataset for complete information, documentation, and data access.",
      "downloadURL": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC113263/",
      "mediaType": "text/html",
      "title": "Official Government Data Source"
    }
  ],
  "identifier": "https://healthdata.gov/api/views/cvzs-dwxw",
  "issued": "2025-07-14",
  "keyword": [
    "5-fluorouracil",
    "biochemical-modulation",
    "colorectal-cancer",
    "methotrexate-leucovorin",
    "nih"
  ],
  "landingPage": "https://healthdata.gov/d/cvzs-dwxw",
  "modified": "2025-09-06",
  "programCode": [
    "009:032"
  ],
  "publisher": {
    "@type": "org:Organization",
    "name": "National Institutes of Health"
  },
  "theme": [
    "NIH"
  ],
  "title": "Schedule-selective biochemical modulation of 5-fluorouracil in advanced colorectal cancer – a phase II study"
}