Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

Last updated: March 31, 2006
Sponsor: Austrian Breast & Colorectal Cancer Study Group
Overall Status: Completed

Phase

3

Condition

Colon Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT00309543
ABCSG 91
  • Ages 18-80
  • All Genders

Study Summary

This clinical investigation examined the influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients’ survival time following surgery for colon carcinoma Stage II.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with histologically verified, operable colon carcinoma Stage II (RO, T3-4,N0, M0)

  • Age: less than 80 years

  • WHO Performance > 2

  • Adequate bone marrow reserve, renal and hepatic functions

  • Informed consent

Exclusion

Exclusion Criteria:

  • Rectal cancer

  • R1or R2 resection; carcinosis peritonei

  • Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy orimmunotherapy

  • Serious concomitant disease, in particular chronically inflammatory large intestine,cardiopathic or metabolic disease, malignant second carcinoma

Study Design

Total Participants: 636
Study Start date:
November 01, 1993
Estimated Completion Date:

Connect with a study center

  • Hospital Guessing

    Guessing, Burgenland 7540
    Austria

    Site Not Available

  • Hospital Oberpullendorf

    Oberpullendorf, Burgenland 7350
    Austria

    Site Not Available

  • Hospital BHB St. Veit/Glan, Surgery

    St. Veit a. d. Glan, Carinthia 9330
    Austria

    Site Not Available

  • State Hospital Wolfsberg

    Wolfsberg, Carinthia 9400
    Austria

    Site Not Available

  • Hospital Hainburg

    Hainburg, Lower Austria 2410
    Austria

    Site Not Available

  • Hospital Krems

    Krems, Lower Austria 3500
    Austria

    Site Not Available

  • Hospital Tulln

    Tulln, Lower Austria 3430
    Austria

    Site Not Available

  • Hospital Waidhofen/Thaya

    Waidhofen a. d. Thaya, Lower Austria 3830
    Austria

    Site Not Available

  • Hospital Wiener Neustadt, Surgery

    Wiener Neustadt, Lower Austria 2700
    Austria

    Site Not Available

  • Medical University of Graz, Oncology

    Graz, Styria 8036
    Austria

    Site Not Available

  • State Hospital Leoben

    Leoben, Styria 8700
    Austria

    Site Not Available

  • Hospital St. Vinzenz

    Zams, Tyrol 6511
    Austria

    Site Not Available

  • State Hospital Kirchdorf

    Kirchdorf, Upper Austria 4560
    Austria

    Site Not Available

  • Hospital Kreuzschwestern Wels

    Wels, Upper Austria 4600
    Austria

    Site Not Available

  • State Hospital Feldkirch

    Feldkirch, Vorarlberg 6807
    Austria

    Site Not Available

  • Paracelsus Medical University Salzburg - Oncology

    Salzburg, 5020
    Austria

    Site Not Available

  • Medical University Vienna, General Hospital

    Vienna, 1090
    Austria

    Site Not Available

  • Wilheminenspital, Internal Medicin I

    Vienna, 1160
    Austria

    Site Not Available

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