Status:
COMPLETED
A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer
Lead Sponsor:
Seoul National University Hospital
Conditions:
Advanced Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The role of perioperative chemotherapy in potentially operable advanced gastric cancer (AGC) with regional lymph node metastasis is still in the area of controversy. The aim of this study is to evalua...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01851941
Start Date
October 1 2004
Last Update
May 13 2013
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744