TerminatedInterventionalPhase 2Updated Oct 3, 2022
Efficacy and Safety of Oxaliplatin Combined With Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Colon Cancer Patients | NCT02415829 | Trialant
Efficacy and Safety of Oxaliplatin Combined With Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Colon Cancer Patients
ClinicalTrials.gov ID
NCT02415829
Lead Sponsor
Fudan UniversityOTHER
Overall Status
Unknown status
Study Type
Interventional
Phase
Phase 2
Enrollment
55Estimated
Last Update Posted
Apr 14, 2015Estimated
Start Date
Nov 2014
Primary Completion Date
Jan 2016Estimated
Brief Summary
The study aims to identify the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with local advanced colorectal cancer.
Colorectal Cancer
capecitabine plus oxaliplatin
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Performance status (ECOG) 0~2
Histologically confirmed colon cancer.
No prior treatment
CT-defined T4 or lymph node-positive colon cancer
Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 8 g/dL Bilirubin level ≤ 1.0 x ULN
AST and ALT < 1.5 x ULN
Serum creatinine ≤ 1.0 x ULN
Life expectancy of ≥ 3 months
Signed written informed consent
Exclusion Criteria:
Final stage with cancer cachexia
Allergy for capecitabine or oxaliplatin
Any evidence of extrahepatic metastases and/or primary tumor recurrence
Severe organ failures or diseases, including: clinically relevant coronary disease, cardiovascular disorder or myocardial infarction within 12 months before study entry, severe psychiatric illness, severe infection and DIC
Primary Purpose
Treatment
Allocation
N/A
Interventional Model
Single Group Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
Department of Colorectal Surgery Fudan University Shanghai Caner CenterRecruiting