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Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced


Phase 2
20 Years
75 Years
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced


Inclusion Criteria:



1. DISEASE CHARACTERISTICS:

Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical
stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)

2. Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy

3. Age:20 to 75

4. Performance status:ECOG 0-2

5. Life expectancy:Not specified

6. Hematopoietic:WBC 4,000-12,000/mm^3;Granulocyte count ≥ 2,000/mm^3;Platelet count ≥
100,000/mm^3;Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L;Bilirubin ≤ 1.5
mg/dL

7. Adequate organ function

8. Able to swallow oral medication

9. Written informed consent

Exclusion Criteria:

1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ

2. Pregnant or breast-feeding women

3. Severe mental disease

4. Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin

5. Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary
fibrosis, or ischemic heart disease

6. Myocardial infarction within six disease-free months

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

5 years

Safety Issue:

Yes

Authority:

China: Ethics Committee

Study ID:

GC-ChinaPLAGH-2010

NCT ID:

NCT01090505

Start Date:

November 2009

Completion Date:

December 2015

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

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