Know Cancer

forgot password

A Randomized Phase II Study of S-1 Versus Capecitabine as First-Line Chemotherapy in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer

Phase 2
60 Years
85 Years
Open (Enrolling)
Stomach Neoplasms

Thank you

Trial Information

A Randomized Phase II Study of S-1 Versus Capecitabine as First-Line Chemotherapy in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer

Inclusion Criteria:

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

2. Age of 70-85 years with Eastern Cooperative Oncology Group (ECOG) performance status
0-2 or age ≥65 and <70 with ECOG performance status ≥ 2

3. Measurable disease as defined by Response Evaluation Criteria In Solid Tumors
(RECIST) Measurable lesions:

- Lesions that can be accurately measured in at least one dimension by any of the

- Computed tomography (CT) of abdomen, pelvis or thorax, if the longest
diameter to be recorded is at least 10 mm with spiral CT

- Chest x-ray, if the lung lesion to be recorded is clearly defined and
surrounded by aerated lung and the diameter to be recorded is at least 20
mm- Physical examination, if the clinically detected lesions are
superficial (e.g., skin nodule and palpable lymph nodes) and at least 10 mm

4. No prior chemotherapy for recurrent and/or metastatic disease (prior
adjuvant/neoadjuvant chemotherapy is allowed at least 6 months has relapsed between
completion of adjuvant/neoadjuvant therapy and enrolment into the therapy; prior S-1
or capecitabine is not allowed)

5. Adequate major organ function including the following:

- Hematopoietic function:

- absolute neutrophil count (ANC)≥1,500/mm3,

- Platelet ≥ 100,000/mm3,

- Hepatic function:

- serum bilirubin =< 1.5 x upper limit of normal (ULN),

- AST/ALT levels =< 2.5 x ULN ( 5 x ULN if liver metastases are present)

- Renal function:

- serum creatinine =< 1.5 x ULN

6. 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. Inadequate cardiovascular function:

- New York Heart Association class III or IV heart disease

- Unstable angina or myocardial infarction within the past 6 months

- History of significant ventricular arrhythmia requiring medication with
antiarrhythmics or significant conduction system abnormality

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

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

6. History of or current brain metastases

7. Psychiatric disorder that would preclude compliance

8. Known dihydropyrimidine dehydrogenase deficiency

9. Patients receiving a concomitant treatment with drugs interacting with S-1 or
capecitabine such as flucytosine, phenytoin, warfarin, lamivudine, or allopurinol et

10. Patients with known active infection with HIV, HBV, or HCV

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

12. 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:

To evaluate each response rate of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer

Outcome Time Frame:

During Chemotherapy

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:

May 2007

Completion Date:

June 2010

Related Keywords:

  • Stomach Neoplasms
  • Stomach Neoplasms
  • Secondary
  • Combination chemotherapy
  • S-1
  • Capecitabine
  • Neoplasms
  • Stomach Neoplasms