Colorectal Neoplasm
Conditions
Keywords
Colorectal Neoplasm, S-1, Capecitabine, Oxaliplatin
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 II trial of combination chemotherapy of oxaliplatin with capecitabine (XELOX) demonstrated good activity and mild toxicity in advanced colorectal cancer. Oxaliplatin and S-1 or capecitabine have distinct mechanisms of action and no overlap of key toxicities. Furthermore, oxaliplatin and fluorouracil were shown to be highly synergistic, not only in preclinical models but also in subsequent clinical trials.
Interventions
DRUGOS (oxalipaltin+S-1)
Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO \[BSA \<1.25 40mg bid (total 80mg/day); BSA ≥1.25 - \<1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)\], divided by two on D1-14 every 21 days
DRUGXELOX (oxalipaltin+capecitabine)
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Sponsors
Sanofi
Hallym University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Safety, time to progression, and overall survival | 4.6 years |
Countries
South Korea
Outcome results
None listed