Advanced Gastric Cancer Clinical Trial
Verified date | May 2013 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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 evaluate the efficacy and toxicity of folinic acid (FA), infusional 5-fluorouracil (5-FU), and oxaliplatin (modified FOLFOX6) in potentially resectable AGC with regional lymph node (LN) metastasis.
Status | Completed |
Enrollment | 52 |
Est. completion date | |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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] = 1.5?109/L, platelet count = 100?109/L, total bilirubin = 1.5?upper limit of normal [ULN], serum transaminases = 2.5?ULN, alkaline phosphatase = 2.5?ULN, serum creatinine = 1.5?ULN 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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | gene expression profile | after 4 cycles of chemotherapy (expected average of 8 weeks) | No | |
Other | early metabolic response by PET-CT | 2 cycles of chemotherapy (expected average of 4 weeks) | No | |
Other | Pharmacologic Genetic Marker | 4 cycles of chemotherapy (expected average of 8 weeks) | No | |
Primary | clinical response rate as assessed using RECIST criteria, with computed tomography (CT) scans at baseline and after 4cycles of chemotherapy | 4 cycles of chemotherapy (expected average of 8 weeks) | No | |
Secondary | Time to progression | From date of study enrollment until the date of first documented progression, assessed up to 60 months | No | |
Secondary | overall survival | From date of study enrollment until the date of first documented progression, assessed up to 60 months | No |
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