treatment of metastatic colorectal cancer MedDRA version: 9.1 Level: LLT Classification code 10061045 Term: Colon neoplasm
Conditions
Interventions
Trade Name: ELOXATIN*IV 1FL POLV 50MG
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Oxaliplatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
GISCAD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:  Histologically confirmed AJCC/UICC high-risk stage II or stage III colon cancer .  Age >18 years  Curative surgery no less than 3 and no more than 8 weeks prior to randomization  ECOG performance Status (ECOG-PS) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:  Macroscopic or microscopic evidence of residual tumor  Previous anti-angiogenic treatment for any malignancy; cytotoxic chemotherapy, radiotherapy or immunotherapy for colon cancer  Other malignancies within the last 5 years  Lactating women  Fertile women not willing to use effective means of contraception  History of clinically relevant psychiatric disability , precluding informed consent  Clinically relevant cardiovascular disease  Current or recent (within the 28 days prior to randomization) treatment with another investigational drug or participation in another investigational study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether a 3-month FOLFOX-4 treatment is not inferior to a 6-month FOLFOX-4 treatment in terms of relapse free survival (RFS) in patients with radically resected stage II/III colon cancer;Secondary Objective: To assess whether a 3-month FOLFOX-4 treatment is not inferior to to a 6-month FOLFOX-4 treatment in terms of overall survival (OS) in patients with radically resected stage II/III colon cancer To evaluate the safety profiles of the treatment groups;Primary end point(s): relapse free survival | — |
Countries
Italy
Outcome results
None listed