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An Open-label, Multicenter, Randomized, 3 Arm Study of S-1 Compared With S-1/CDDP, or S-1/CDDP Compared With 5-FU/CDDP in Patients With Advanced Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease


Phase 3
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

An Open-label, Multicenter, Randomized, 3 Arm Study of S-1 Compared With S-1/CDDP, or S-1/CDDP Compared With 5-FU/CDDP in Patients With Advanced Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease


Inclusion Criteria:



- Non-prior chemotherapy treated advanced gastric adenocarcinoma

- Age 18 and over

- Performance status 0, 1, or 2 (ECOG)

- Life expectancy 3 months

- Hematopoietic WBC lower limit of normal-12,000/mm^3 Absolute granulocyte count ≥
2,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL

- Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤
1.5 mg/dL

- Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

- Interstitial pneumonia, pulmonary fibrosis

- Myocardial infarction within the last 6 months, severe/unstable angina, congestive
heart failure

- Intestinal paralysis, intestinal obstruction, uncontrollable diabetes

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:

Response rate

Outcome Time Frame:

every course for first three courses, then every other course

Principal Investigator

Jin Maolin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beijing Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

SC101

NCT ID:

NCT00202969

Start Date:

July 2005

Completion Date:

June 2007

Related Keywords:

  • Gastric Cancer
  • Stomach cancer
  • Stomach Neoplasms

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