Stage III colon cancer MedDRA version: 9.1 Level: LLT Classification code 10009955 Term: Colon cancer stage III
Conditions
Interventions
Trade Name: Levofolinate de Calcium
Pharmaceutical Form: Solution for infusion
Other descriptive name: Leucovorin
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 1
Sponsors
GERCOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients who have undergone surgery for colon cancer, defined as a tumor location >12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (High rectum), without gross or microscopic evidence of residual disease after surgery with curative intent. •Histologically confirmed AJCC/UICC stage III adenocarcinoma colon cancer. •Age >18 years •Curative surgery 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 (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in ascites or peritoneal carcinomatosis resected “en bloc”) •Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix) •Pregnant or lactating women •Clinically relevant cardiovascular disease (ischemic myocardial infarction in the last year and/or unstable ischemic cardiopathy) •History or current evidence on physical examination of central nervous system disease or peripheral neuropathy = grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0 •Known hypersensitivity reaction to any of the components of study treatments. •Current or recent (within 28 days prior to randomization) treatment with another investigational drug or participation in another investigational study •Subject unwilling or unable to comply with study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether a 3-month modified FOLFOX 6 treatment is not inferior to a 6-month modified FOLFOX 6 treatment in terms of disease free survival (DFS) in patients with radically resected stage III colon cancer ;Secondary Objective: -To assess whether 3-month modified FOLFOX 6 treatment is not inferior to 6-month modified FOLFOX 6 treatment in terms of overall survival (OS) in patients with radically resected stage III colon cancer -To evaluate the safety profiles of the treatment groups ;Primary end point(s): Disease free survival, defined as local or distant recurrence of colon cancer or death of any cause. Second primary colorectal cancer or other primary cancer will be ignored, and loss to follow-up will be censored. | — |
Countries
France
Outcome results
None listed