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Phase 2
18 Years
75 Years
Not Enrolling
Advanced Gastric Cancer

Thank you

Trial Information

Inclusion Criteria:

- Previously untreated patients with pathologically proven advanced gastric
adenocarcinoma with regional LN metastasis (clinical stage: cT2-4 and N+)

- At least one measurable regional lymph node metastasis according to the Response
Evaluation Criteria in Solid Tumors (RECIST v. 1.0)

- age between 18 and 75 years

- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1

- no prior chemotherapy or radiotherapy

- adequate bone marrow, hepatic and renal function (absolute neutrophil count [ANC] ≥
1.5ⅹ109/L, platelet count ≥ 100ⅹ109/L, total bilirubin ≤ 1.5ⅹupper limit of normal
[ULN], serum transaminases ≤ 2.5ⅹULN, alkaline phosphatase ≤ 2.5ⅹULN, serum
creatinine ≤ 1.5ⅹULN or actual or calculated creatinine clearance ≥ 50 mL/min).

Exclusion Criteria:

- clinical stage T1 tumors

- clinical or radiologic evidence of distant metastasis

- intestinal obstruction or impending obstruction

- active tumor bleeding

- interstitial pneumonitis or symptomatic pulmonary fibrosis

- peripheral neuropathy of National Cancer Institute Common Toxicity Criteria (NCI-CTC)
grade ≥1

- pregnant or breastfeeding patients

- other serious diseases

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

clinical response rate as assessed using RECIST criteria, with computed tomography (CT) scans at baseline and after 4cycles of chemotherapy

Outcome Time Frame:

4 cycles of chemotherapy (expected average of 8 weeks)

Safety Issue:



Korea: Food and Drug Administration

Study ID:

H 0406127 007



Start Date:

October 2004

Completion Date:

Related Keywords:

  • Advanced Gastric Cancer
  • Stomach Neoplasms