Clinical trial NCT01851941: A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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 \[ANC\] ≥ 1.5ⅹ109/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 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

Primary outcomes:
measure: clinical response rate as assessed using RECIST criteria, with computed tomography (CT) scans at baseline and after 4cycles of chemotherapy
timeFrame: 4 cycles of chemotherapy (expected average of 8 weeks)
Secondary outcomes:
measure: Time to progression
timeFrame: From date of study enrollment until the date of first documented progression, assessed up to 60 months
measure: overall survival
timeFrame: From date of study enrollment until the date of first documented progression, assessed up to 60 months
Other outcomes:
measure: gene expression profile
timeFrame: after 4 cycles of chemotherapy (expected average of 8 weeks)
measure: early metabolic response by PET-CT
timeFrame: 2 cycles of chemotherapy (expected average of 4 weeks)
measure: Pharmacologic Genetic Marker
timeFrame: 4 cycles of chemotherapy (expected average of 8 weeks)
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: