A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer

Advanced Gastric Cancer Clinical Trial

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. 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

• Advanced Gastric Cancer
• Stomach Neoplasms

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