Advanced Gastric CancerPhase 2NCT02142322
Perioperative mFOLFOX-6 in Locally Advanced Gastric Cancer
A Phase 2 study testing MODIFIED FOLFOX6 in people with Advanced Gastric Cancer, run by Seoul National University Hospital at 2 sites in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- MODIFIED FOLFOX6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jun 2004to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Seongnam
Seoul National University Hospital
Seoul
About this study
Official title: 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.
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)
- Conditions
- Advanced Gastric Cancer
- Being tested
- MODIFIED FOLFOX6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MODIFIED FOLFOX6Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Modified FOLFOX6 | 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, 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. Receives: Drug: MODIFIED FOLFOX6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
response rate by the RECIST criteria
Measured: 22 weeks
Secondary outcomes (4)
Grade 3-4 toxicity
toxicity : Grade 3-4 toxicity by the NCI-CTCAE v3.0
Measured: one year
median overall survival
median value of the time from enrollment to the patient's death
Measured: 1 year
median time to treatment failure
median value of the time from enrollment to disease progression, withdrawl of consent, or unacceptable toxicity
Measured: 1 year
resection rate
the rate of patients whose tumor was completely resected
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startJun 2004
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seock-Ah Im, Seoul National University Hospital
- Investigators
- Seock-Ah Im, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142322
- Sponsor's protocol ID
- H-0406-127-007
- Status last verified
- May 2014
- First submitted
- 28 Jun 2011
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer
- ClinicalTrials.gov ID
- NCT02142322
- Acronym / sponsor ID
- H-0406-127-007
- Conditions
- Advanced Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II Trial of Perioperative Chemotherapy with Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6)in Patients with Locally Advanced Operable Gastric Cancer.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified FOLFOX6 | Experimental | Drug: MODIFIED FOLFOX6Modified 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MODIFIED FOLFOX6Modified 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 |
Primary outcome
response rate
Time frame: 22 weeks
response rate by the RECIST criteria
4 secondary outcomes
Grade 3-4 toxicity
Time frame: one year
median overall survival
Time frame: 1 year
median time to treatment failure
Time frame: 1 year
resection rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
Related trials for Advanced Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seock-Ah Im, MD, PhD principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MODIFIED FOLFOX6 in people with Advanced Gastric Cancer, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.