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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00309543
Other study ID # ABCSG 91
Secondary ID
Status Completed
Phase Phase 3
First received March 31, 2006
Last updated March 31, 2006
Start date November 1993

Study information

Verified date March 2006
Source Austrian Breast & Colorectal Cancer Study Group
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and Women
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 636
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Criteria:

- Rectal cancer

- R1or R2 resection; carcinosis peritonei

- Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Fluorouracil

Leucovorin


Locations

Country Name City State
Austria State Hospital Feldkirch Feldkirch Vorarlberg
Austria Medical University of Graz, Oncology Graz Styria
Austria Hospital Guessing Guessing Burgenland
Austria Hospital Hainburg Hainburg Lower Austria
Austria State Hospital Kirchdorf Kirchdorf Upper Austria
Austria Hospital Krems Krems Lower Austria
Austria State Hospital Leoben Leoben Styria
Austria Hospital Oberpullendorf Oberpullendorf Burgenland
Austria Paracelsus Medical University Salzburg - Oncology Salzburg
Austria Hospital BHB St. Veit/Glan, Surgery St. Veit a. d. Glan Carinthia
Austria Hospital Tulln Tulln Lower Austria
Austria Medical University Vienna, General Hospital Vienna
Austria Wilheminenspital, Internal Medicin I Vienna
Austria Hospital Waidhofen/Thaya Waidhofen a. d. Thaya Lower Austria
Austria Hospital Kreuzschwestern Wels Wels Upper Austria
Austria Hospital Wiener Neustadt, Surgery Wiener Neustadt Lower Austria
Austria State Hospital Wolfsberg Wolfsberg Carinthia
Austria Hospital St. Vinzenz Zams Tyrol

Sponsors (1)

Lead Sponsor Collaborator
Austrian Breast & Colorectal Cancer Study Group

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival
See also
  Status Clinical Trial Phase
Recruiting NCT06434896 - Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial N/A
Recruiting NCT04089631 - Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation Phase 3
Active, not recruiting NCT05421702 - Comparison Between Results of 2 Laparoscopic Surgical Procedures in Operable Colon Cancer Cases in Upper Egypt N/A
Recruiting NCT06108310 - ArTificial inTelligence-based RAdiogenomics in Colon Tumors
Recruiting NCT05194878 - Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers Phase 3

External Links