- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02142322
Perioperative mFOLFOX-6 in Locally Advanced Gastric Cancer
May 15, 2014 updated by: Seoul National University Hospital
A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer
This is a Phase II Trial of Perioperative Chemotherapy with Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6)in Patients with Locally Advanced Operable Gastric Cancer.
Study Overview
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)
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
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-
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Seongnam, Korea, Republic of
- Seoul National University Bundang Hospital
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Seoul, Korea, Republic of
- Seoul National University Hospital
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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
16 years and older (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 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 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.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
response rate
Time Frame: 22 weeks
|
response rate by the RECIST criteria
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22 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
toxicity
Time Frame: one year
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toxicity : Grade 3-4 toxicity by the NCI-CTCAE v3.0
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one year
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median overall survival
Time Frame: 1 year
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median value of the time from enrollment to the patient's death
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1 year
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median time to treatment failure
Time Frame: 1 year
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median value of the time from enrollment to disease progression, withdrawl of consent, or unacceptable toxicity
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1 year
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resection rate
Time Frame: 1 year
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the rate of patients whose tumor was completely resected
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Seock-Ah Im, MD, PhD, 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
June 1, 2004
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
June 28, 2011
First Submitted That Met QC Criteria
May 15, 2014
First Posted (Estimate)
May 20, 2014
Study Record Updates
Last Update Posted (Estimate)
May 20, 2014
Last Update Submitted That Met QC Criteria
May 15, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-0406-127-007
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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