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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

Page last updated: August 23, 2015

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