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

May 8, 2013 updated by: Seock-Ah Im, Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: mFOLFOX6
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 )
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical response rate as assessed using RECIST criteria, with computed tomography (CT) scans at baseline and after 4cycles of chemotherapy
Time Frame: 4 cycles of chemotherapy (expected average of 8 weeks)
4 cycles of chemotherapy (expected average of 8 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: From date of study enrollment until the date of first documented progression, assessed up to 60 months
From date of study enrollment until the date of first documented progression, assessed up to 60 months
overall survival
Time Frame: From date of study enrollment until the date of first documented progression, assessed up to 60 months
From date of study enrollment until the date of first documented progression, assessed up to 60 months

Other Outcome Measures

Outcome Measure
Time Frame
gene expression profile
Time Frame: after 4 cycles of chemotherapy (expected average of 8 weeks)
after 4 cycles of chemotherapy (expected average of 8 weeks)
early metabolic response by PET-CT
Time Frame: 2 cycles of chemotherapy (expected average of 4 weeks)
2 cycles of chemotherapy (expected average of 4 weeks)
Pharmacologic Genetic Marker
Time Frame: 4 cycles of chemotherapy (expected average of 8 weeks)
4 cycles of chemotherapy (expected average of 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

May 6, 2013

First Submitted That Met QC Criteria

May 8, 2013

First Posted (ESTIMATE)

May 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 8, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H 0406127 007 (OTHER: Seoul National University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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