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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01851941
Other study ID # H 0406127 007
Secondary ID H 0406127 007
Status Completed
Phase Phase 2
First received May 6, 2013
Last updated May 8, 2013
Start date October 2004

Study information

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

Clinical Trial 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 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.


Recruitment information / eligibility

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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
mFOLFOX6 (folinic acid, 5-fluorouracil, and oxaliplatin )
Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, which is repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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