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

NCT01851941 | Completed Phase 2

• 1 other identifier: H 0406127 007
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Time to progression

  From date of study enrollment until the date of first documented progression, assessed up to 60 months

• overall survival

  From date of study enrollment until the date of first documented progression, assessed up to 60 months

Other Outcomes (3)

• gene expression profile

  after 4 cycles of chemotherapy (expected average of 8 weeks)

• early metabolic response by PET-CT

  2 cycles of chemotherapy (expected average of 4 weeks)

• Pharmacologic Genetic Marker

  4 cycles of chemotherapy (expected average of 8 weeks)

Study Arms (1)

mFOLFOX6

EXPERIMENTAL

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.

Drug: mFOLFOX6 (folinic acid, 5-fluorouracil, and oxaliplatin )

Interventions

mFOLFOX6 (folinic acid, 5-fluorouracil, and oxaliplatin ) DRUG

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.

mFOLFOX6

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Leucovorin; Fluorouracil; Oxaliplatin

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 13, 2013
• Study Start: October 1, 2004
• Primary Completion: June 1, 2008
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

KR (1)