Clinical trial NCT00309543: Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B
Official title: A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colon Cancer Stage II
Keywords: Fluorouracil
Leucovorin
Colon cancer
Lead sponsor: Austrian Breast & Colorectal Cancer Study Group
Sponsor class: NETWORK
First posted: 2006-04-03
Enrollment: 636
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Overall survival
Secondary outcomes:
Other outcomes:
Locations:
city: Guessing
country: Austria
facility: Hospital Guessing
state: Burgenland
city: Oberpullendorf
country: Austria
facility: Hospital Oberpullendorf
state: Burgenland
city: St. Veit a. d. Glan
country: Austria
facility: Hospital BHB St. Veit/Glan, Surgery
state: Carinthia
city: Wolfsberg
country: Austria
facility: State Hospital Wolfsberg
state: Carinthia
city: Hainburg
country: Austria
facility: Hospital Hainburg
state: Lower Austria
city: Krems
country: Austria
facility: Hospital Krems
state: Lower Austria
city: Tulln
country: Austria
facility: Hospital Tulln
state: Lower Austria
city: Waidhofen a. d. Thaya
country: Austria
facility: Hospital Waidhofen/Thaya
state: Lower Austria
city: Wiener Neustadt
country: Austria
facility: Hospital Wiener Neustadt, Surgery
state: Lower Austria
city: Graz
country: Austria
facility: Medical University of Graz, Oncology
state: Styria
city: Leoben
country: Austria
facility: State Hospital Leoben
state: Styria
city: Zams
country: Austria
facility: Hospital St. Vinzenz
state: Tyrol
city: Kirchdorf
country: Austria
facility: State Hospital Kirchdorf
state: Upper Austria
city: Wels
country: Austria
facility: Hospital Kreuzschwestern Wels
state: Upper Austria
city: Feldkirch
country: Austria
facility: State Hospital Feldkirch
state: Vorarlberg
city: Salzburg
country: Austria
facility: Paracelsus Medical University Salzburg - Oncology
city: Vienna
country: Austria
facility: Medical University Vienna, General Hospital
city: Vienna
country: Austria
facility: Wilheminenspital, Internal Medicin I
Study officials:
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Raimund Jakesz, MD
role: PRINCIPAL_INVESTIGATOR
References: