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A Randomized Phase II Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma

Phase 2
18 Years
Open (Enrolling)
Stomach Neoplasms

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Trial Information

A Randomized Phase II Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma

Inclusion Criteria:

1. Histologically or cytologically confirmed gastric adenocarcinoma with recurrent
and/or metastatic disease

2. Age ≥ 18 years

3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

4. Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors
(RECIST) or non-measurable evaluable

5. No prior treatment for recurrent and/or metastatic disease (prior
adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between
completion of adjuvant/neoadjuvant therapy and enrolment into the study; prior
oxaliplatin is not allowed)

6. Adequate major organ function including the following: Hematopoietic function: ANC >=
1,500/mm3, Platelet >= 100,000/mm3, Hepatic function: serum bilirubin =< 1.5 x ULN,
AST/ALT levels =< 2.5 x ULN (=< 5 x ULN if liver metastases are present)Renal
function: serum creatinine =< 1.5 x ULN

7. Patients should sign a written informed consent before study entry

Exclusion Criteria:

1. Lack of physical integrity of the upper gastrointestinal tract or malabsorption
syndrome (e.g. patients with partial or total gastrectomy can enter the study, but
not those with a jejunostomy probe), or inability to take oral medication

2. Patients with active (significant or uncontrolled) gastrointestinal bleeding

3. Residual relevant toxicity resulting from previous therapy (with the exception of
alopecia) ≥ grade 2 NCI-CTCAE version 3.0

4. Prior and/or current history of peripheral neuropathy

- grade 1 NCI-CTCAE version 3.0

5. Inadequate cardiovascular function:New York Heart Association class III or IV heart
diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of
significant ventricular arrhythmia requiring medication with antiarrhythmics or
significant conduction system abnormality

6. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose
control may be jeopardized by complications of study therapy

7. Other malignancy within the past 3 years except non-melanomatous skin cancer or
carcinoma in situ of the cervix

8. History of or current brain metastases

9. Psychiatric disorder that would preclude compliance

10. Females with a positive or no pregnancy test (within 7 days before treatment start)
until childbearing potential can be otherwise excluded (postmenopausal i.e.
amenorrheic for at least 2 years, hysterectomy or oophorectomy)

11. Subjects with reproductive potential not willing to use an effective method of

12. Lactating women

13. Known dihydropyrimidine dehydrogenase deficiency

14. Patients receiving a concomitant treatment with drugs interacting with S-1 such as
flucytosine, phenytoin, or warfarin et al.

15. Major surgery within 4 weeks of start of study treatment, without complete recovery

16. Radiotherapy within 4 weeks of start of study treatment; 2 weeks interval allowed if
palliative radiotherapy was given to bone metastatic site and patient recovered from
any acute toxicity

Type of Study:


Study Design:

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

Outcome Measure:

Overall survial in the two treatment arms

Outcome Time Frame:

During study period

Safety Issue:


Principal Investigator

Sook Ryun Park, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

July 2007

Completion Date:

August 2010

Related Keywords:

  • Stomach Neoplasms
  • Stomach Neoplasms
  • Secondary
  • Combination chemotherapy
  • S-1
  • oxaliplatin
  • Neoplasms
  • Carcinoma
  • Stomach Neoplasms