Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) for Advanced Colorectal Cancer
Information source: Hallym University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Neoplasm
Intervention: OS (oxalipaltin+S-1) (Drug); XELOX (oxalipaltin+capecitabine) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Hallym University Medical Center Official(s) and/or principal investigator(s): Dae Young Zang, MD, PhD, Principal Investigator, Affiliation: Hallym University Medical Center
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.
Clinical Details
Official title: A Randomized Phase II Study of Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) in Patients With Advanced or Recurrent Colorectal Cancer
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: overall response rate
Secondary outcome: Safety, time to progression, and overall survival
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Hallym University Medical Center, Anyang 431-070, Korea, Republic of
Additional Information
Starting date: April 2008
Last updated: October 4, 2012
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