A Phase 2 interventional study of OS (oxalipaltin+S-1) and XELOX (oxalipaltin+capecitabine) in Colorectal Neoplasm, sponsored by Hallym University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-10-05.
Sponsored by Hallym University Medical Center · Phase 2, Interventional, and Treatment
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 88 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Hallym University Medical Center is the lead sponsor of 52 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
OS (oxaliplatin + 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
Drug: OS (oxalipaltin+S-1)
XELOX (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
Drug: XELOX (oxalipaltin+capecitabine)
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
Also known as: Eloxatin, TS-1
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Also known as: Eloxatin, Xeloda
overall response rate
Time frame: 4 years
Safety, time to progression, and overall survival
Time frame: 4.6 years
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Hallym University Medical Center