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CompletedNCT02142322Updated Apr 17, 2025

Perioperative mFOLFOX-6 in Locally Advanced Gastric Cancer

A Phase 2 interventional study of MODIFIED FOLFOX6 in Advanced Gastric Cancer, sponsored by Seoul National University Hospital. Completed at 2 sites in Korea, Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-17.

Sponsored by Seoul National University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study summary

This is a Phase II Trial of Perioperative Chemotherapy with Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6)in Patients with Locally Advanced Operable Gastric Cancer.

Read the detailed description

The main purpose of this study is to evaluate response rate (clinical response and pathological response) of oxaliplatin, 5-fluorouracil, leucovorin(MODIFIED FOLFOX6)

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Conditions studied

  • Advanced Gastric Cancer

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 52 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Previously untreated patients with pathologically proven advanced gastric adenocarcinoma with regional LN metastasis are eligible for this study (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) [17] is required. Other eligibility criteria include age between 18 and 75 years, Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, no prior chemotherapy or radiotherapy, and 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

Exclusion Criteria:

  • Exclusion criteria include 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, and other serious diseases.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Modified FOLFOX6

    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, 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: MODIFIED FOLFOX6

Interventions

  • DrugMODIFIED FOLFOX6

    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, 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.

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What researchers measure

Primary outcomes

  1. response rate

    response rate by the RECIST criteria

    Time frame: 22 weeks

Secondary outcomes

  1. Grade 3-4 toxicity

    toxicity : Grade 3-4 toxicity by the NCI-CTCAE v3.0

    Time frame: one year

  2. median overall survival

    median value of the time from enrollment to the patient's death

    Time frame: 1 year

  3. median time to treatment failure

    median value of the time from enrollment to disease progression, withdrawl of consent, or unacceptable toxicity

    Time frame: 1 year

  4. resection rate

    the rate of patients whose tumor was completely resected

    Time frame: 1 year

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Study locations

2 sites
  • Seoul National University Bundang Hospital
    Seongnam, Korea, Republic of
  • Seoul National University Hospital
    Seoul, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02142322
Lead sponsor
Seoul National University Hospital
Responsible party
Seock-Ah Im (Professor, Seoul National University Hospital) — Principal investigator
First posted
May 20, 2014
Start date
Jun 2004
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Apr 17, 2025

Study contacts

Seock-Ah Im, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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