Trial | NCT00309530  Report issue

Title

Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C
A Prospectively Randomized Phase III Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Patients With Operated Colon Carcinoma Dukes C (Stage III; T1-4, N1-30, M0).

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    598
This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple combination, in terms of recurrence-free and overall survival in curatively operable colon carcinoma Stage III.
Study Started
Oct 31
1990
Last Update
Apr 03
2006
Estimate

Drug 5-fluorouracil, levamisol, interferon

Criteria 

Inclusion Criteria:

Patients with histologically verified, curatively operated colon carcinoma Stage III (R0, T1-4, N1-3, M0)
Age: less than 80 years
WHO Performace Status > 2
Adequate bone marrow reserve
Informed consent

Exclusion Criteria:

Rectal cancer
R1, R2, carcinosis peritonei
Start of chemo- or chemo-immunotherapy > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic disease, malignant second carcinoma
No Results Posted