Status:
COMPLETED
Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) for Advanced Colorectal Cancer
Lead Sponsor:
Hallym University Medical Center
Collaborating Sponsors:
Sanofi
Conditions:
Colorectal Neoplasm
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (OS) and Oxaliplatin and Capecitabine (XELOX) in patients with advance or recurrent colorectal cancer.
Detailed Description
Oxaliplatin and oral fluoropyrimidines (capecitabine or S-1) are active agents for colorectal cancer. Recent a phase II trial of combination chemotherapy of oxaliplatin with S-1 (OS) and several phase...
Eligibility Criteria
Inclusion
- Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred
- Unresectable, locally advanced or metastatic
- At least one uni-dimensional measurable lesion by RECIST criteria
- Age 18 to 75 years old
- Estimated life expectancy ≥3 months
- ECOG performance status ≤2
- Adequate bone marrow function (WBCs ≥ 4,000/µL or absolute neutrophil count ≥ 1,500/µL, platelets ≥ 100,000/µL)
- Adequate kidney function (creatinine \< 1.5 mg/dL)
- Adequate liver function (bilirubin \< 2.0 mg/dL, transaminase levels \<2.5 times the upper normal limit)
- Written informed consent
Exclusion
- Other tumor type than adenocarcinoma
- Previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin)
- Presence of CNS metastasis, psychosis, or seizure
- Obvious bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00677144
Start Date
April 1 2008
End Date
April 1 2012
Last Update
October 5 2012
Active Locations (1)
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1
Hallym University Medical Center
Anyang, South Korea, 431-070