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Bending the Curve Trial by Trial
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Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma

Needs review

N = 1,296

Population
Patients with resected colon cancer that was locally invasive (stage B2) or had regional nodal involvement (stage C); 1296 randomly assigned. The 1995 final report covers 929 eligible stage III (Dukes C) patients.
Design
Randomised comparison after resection of colon cancer. Patients were assigned to observation or to one year of levamisole combined with fluorouracil; patients with stage C disease could also be assigned to levamisole alone. The 1990 abstract does not state a phase or a primary endpoint.
Arms
  • Observation (control): Surgery followed by observation
  • Levamisole plus fluorouracil (experimental): One year of levamisole plus fluorouracil (1995 report: levamisole 50 mg orally three times daily for 3 days every 2 weeks; fluorouracil 450 mg/m2 IV daily for 5 days, then weekly from day 28 for 48 weeks)
  • Levamisole alone (experimental): Levamisole alone for one year (stage C patients only)
People
Moertel CG
Primary publication: Moertel CG, Fleming TR, Macdonald JS, Haller DG, Laurie JA, Goodman PJ, et al. Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N Engl J Med. 1990;322(6):352-8. PubMedDOI

Appears in

Sources

  1. Moertel CG, Fleming TR, Macdonald JS, Haller DG, Laurie JA, Goodman PJ, et al. Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N Engl J Med. 1990;322(6):352-8.

    PubMedDOI