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Randomized Phase II Study of S-1 (SOX) or Capecitabine (XELOX) in Combination With Oxaliplatin in Patients With Recurrent or Metastatic Gastric Cancer

Phase 2
18 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

Randomized Phase II Study of S-1 (SOX) or Capecitabine (XELOX) in Combination With Oxaliplatin in Patients With Recurrent or Metastatic Gastric Cancer



- To evaluate the time to progression in patients with recurrent or metastatic gastric
cancer treated with oxaliplatin in combination with S-1 vs capecitabine.


- To assess progression-free survival, overall response, disease-control rate,
time-to-treatment failure, response duration, time to response, overall survival,
safety, quality of life, pharmacogenetics, and psychologic distress/coping strategy.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral S-1 twice daily on days 1-14 and oxaliplatin IV over 2
hours on day 1.

- Arm II: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin as
in arm I.

Courses in both arms repeat every 3 weeks in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months for 6 months.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the stomach

- Unresectable advanced disease or recurrent disease after resection

- At least one radiographically documented (CT scan or MRI) measurable or evaluable
lesion in a previously non-irradiated area according to RECIST

- No clinical evidence of brain metastases or history of other CNS disease unless
adequately treated


- ECOG performance status 0-2

- Estimated life expectancy > 3 months

- Hemoglobin ≥ 9 g/dL

- White blood cell ≥ 4,000/µL

- ANC ≥ 2,000/µL

- Platelets ≥ 100,000/µL

- Bilirubin ≤ 1.25 times upper limit of normal (ULN) (≤ 2.0 times ULN if hepatic
metastasis present)

- Serum creatinine ≤ 1.5 times ULN

- Creatinine clearance ≥ 60 mL/min

- AST/ALT ≤ 3.0 times ULN (≤ 5.0 times ULN if hepatic metastasis present)

- Alkaline phosphatase ≤ 3.0 times ULN (≤ 5.0 times ULN if bone metastasis present)

- Must have an intact gastrointestinal tract

- Able to take oral medications

- No medically uncontrolled severe infections or complications

- No prior malignancy other than gastric cancer in the last 5 years except for basal
cell cancer of the skin or preinvasive cancer of the cervix

- Not pregnant or nursing

- No neuropathy ≥ grade 2

- No clinically relevant heart disease

- No evidence of past medical history or psychosocial dysfunction that contraindicates
the use of an investigational drug or puts the patient at risk

- No dementia, altered mental status, or any psychiatric condition that would prohibit
the understanding or rendering of informed consent

- No uncontrolled hepatitis B or C, chronic liver disease, or diabetes mellitus

- No other evidence of inappropriate suspicious condition


- No prior chemotherapy for advanced or recurrent disease

- Prior adjuvant chemotherapy allowed if finished > 6 months before start of study

- No prior therapeutic radiotherapy

- Prior palliative radiotherapy allowed if it was not done for primary, evaluable,
or intraabdominal lesions

- No prior capecitabine or oxaliplatin

- No other concurrent chemotherapy or radiotherapy (except localized radiotherapy for
pain relief)

- No concurrent chemically related analogues, such as warfarin, phenytoin, or

- No concurrent steroid therapy except as follows:

- Prophylactic use for hypersensitivity control or antiemetic purpose allowed

- Chronic low dose of steroid (less than methylprednisolone 20 mg or equivalent
dose) allowed

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:


Principal Investigator

Hyun C. Chung, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yonsei University



Study ID:




Start Date:

January 2009

Completion Date:

Related Keywords:

  • Gastric Cancer
  • recurrent gastric cancer
  • adenocarcinoma of the stomach
  • stage IIIA gastric cancer
  • stage IIIB gastric cancer
  • stage IIIC gastric cancer
  • stage IV gastric cancer
  • Stomach Neoplasms