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A Randomized Phase II Study of Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) in Patients With Advanced or Recurrent Colorectal Cancer


Phase 2
18 Years
75 Years
Not Enrolling
Both
Colorectal Neoplasm

Thank you

Trial Information

A Randomized Phase II Study of Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) in Patients With Advanced 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Dae Young Zang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hallym University Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

HMC-HO-GI-0712

NCT ID:

NCT00677144

Start Date:

April 2008

Completion Date:

April 2012

Related Keywords:

  • Colorectal Neoplasm
  • Colorectal Neoplasm
  • S-1
  • Capecitabine
  • Oxaliplatin
  • Neoplasms
  • Colorectal Neoplasms

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