Gastric CancerPhase 2FOLFOX6NCT02226380
FOLFOX6 as Neoadjuvant Chemotherapy in Local Advanced Gastric Cancer
A Phase 2 study testing mFOLFOX6 regimen in people with Gastric Cancer and Effects of Chemotherapy, run by Peking Union Medical College Hospital at 2 sites in China.
Trial summary
Purpose: This aim of the study is to evaluate the efficacy and safety of neoadjuvant chemotherapy with the modified FOLFOX6(mFOLFOX6) regimen and its impact on survival on a series in local advanced gastric cancer patients. Patients and methods: The study is a prospective non-randomized study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Effects of Chemotherapy, Surgery
- What is being tested?
- mFOLFOX6 regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2013to Dec 2014
- 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
- Eligibility criteria included histologically confirmed gastric cancer, the gastro-oesophageal junction(GEJ) may be involved, but the bulk of the tumour has to be in the stomach; age ≥18 years old, ECOG performance status score ≤2, no prior chemotherapy, TNM stage of T2-T4 or positive regional lymph nodes by endoscopic ultrasound or computed tomography (CT), and adequate hematological, heart, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL).
Who cannot join
- Patients with second malignancies or evidence of severe or uncontrolled systemic disease were excluded.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Department of Oncology and Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100032
Xiang Wang, Master, +86(10)69158315, wangxiang5123@126.com
Xiao yi Li, Doctor
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Xiao yi Li, Mater, +86(10)69154910, li.xiaoyi@263.net
About this study
Official title: A Phase II Study of Neoadjuvant Chemotherapy With Modified FOLFOX6 Regimen and Effects of Tumor Regression in Locally Advanced Gastric Cancer
Purpose: This aim of the study is to evaluate the efficacy and safety of neoadjuvant chemotherapy with the modified FOLFOX6(mFOLFOX6) regimen and its impact on survival on a series in local advanced gastric cancer patients.
Patients and methods: The study is a prospective non-randomized study. Patients with histopathologically confirmed and locally advanced gastric cancer(T2-T4 or N+) are enrolled in the study. Patients are given mFOLFOX6 scheme for 3 cycles.A radical gastrectomy and a D2 lymphadenectomy was will be scheduled 3-6 weeks after the completion of the preoperative chemotherapy. Down-staging is assessed comparing pretreatment clinical staging with postoperative pathologic staging on patients who underwent radical surgery. Tumor down-staging and the grade of pathologic response are included in a statistical correlation between tumor regression induced by mFOLFOX6 neoadjuvant chemotherapy and survival.The primary endpoint is 3-year overall survival, secondary endpoints are disease-free survival, R0 resection rate, toxicity and prediction of response.
- Conditions
- Gastric Cancer, Effects of Chemotherapy, Surgery
- Being tested
- mFOLFOX6 regimen
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOX6 regimenDrug
oxaliplatin 85 mg/m2 and folinic acid 400 mg/m2 are administered intravenously for 2 hours on day 1 following by 5-FU at 2,400 mg/m2 by continuous infusion for 46hours every 2 weeks for 3 cycles before performing surgery
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOX6,chemotherapy regimen | Experimental | oxaliplatin 85 mg/m2 and folinic acid 400 mg/m2 are administered intravenously for 2 hours on day 1 following by 5-FU at 2,400 mg/m2 by continuous infusion for 46hours every 2 weeks for 3 cycles before performing surgery Receives: Drug: mFOLFOX6 regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 3-year overall survival rate in patients who will receive mFOLFOX6 regimen as neoadjuvant chemotherapy regimen
Measured: 3 years
Secondary outcomes (1)
The 3-year disease-free survival rate in the patients who will receive mFOLFOX6 regimen neoadjuvant chemotherapy regimen
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiang Wang, Master, Study director, Department of Medical Oncology Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226380
- Sponsor's protocol ID
- PUMCH-JZ
- Acronym
- FOLFOX6
- Status last verified
- Aug 2014
- First submitted
- 24 Aug 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Li ZY, Koh CE, Bu ZD, Wu AW, Zhang LH, Wu XJ, Wu Q, Zong XL, Ren H, Tang L, Zhang XP, Li JY, Hu Y, Shen L, Ji JF. Neoadjuvant chemotherapy with FOLFOX: improved outcomes in Chinese patients with locally advanced gastric cancer. J Surg Oncol. 2012 Jun 15;105(8):793-9. doi: 10.1002/jso.23009. Epub 2011 Dec 20.
PubMed 22189752
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Chemotherapy With Modified FOLFOX6 Regimen and Effects of Tumor Regression in Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02226380
- Acronym / sponsor ID
- FOLFOX6 / PUMCH-JZ
- Conditions
- Gastric Cancer, Effects of Chemotherapy, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 27 Aug 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.
Purpose: This aim of the study is to evaluate the efficacy and safety of neoadjuvant chemotherapy with the modified FOLFOX6(mFOLFOX6) regimen and its impact on survival on a series in local advanced gastric cancer patients.
Patients and methods: The study is a prospective non-randomized study. Patients with histopathologically confirmed and locally advanced gastric cancer(T2-T4 or N+) are enrolled in the study. Patients are given mFOLFOX6 scheme for 3 cycles.A radical gastrectomy and a D2 lymphadenectomy was will be scheduled 3-6 weeks after the completion of the preoperative chemotherapy. Down-staging is assessed comparing pretreatment clinical staging with postoperative pathologic staging on patients who underwent radical surgery. Tumor down-staging and the grade of pathologic response are included in a statistical correlation between tumor regression induced by mFOLFOX6 neoadjuvant chemotherapy and survival.The primary endpoint is 3-year overall survival, secondary endpoints are disease-free survival, R0 resection rate, toxicity and prediction of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mFOLFOX6,chemotherapy regimen | Experimental | Drug: mFOLFOX6 regimenoxaliplatin 85 mg/m2 and folinic acid 400 mg/m2 are administered intravenously for 2 hours on day 1 following by 5-FU at 2,400 mg/m2 by continuous infusion for 46hours every 2 weeks for 3 cycles before performing surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligibility criteria included histologically confirmed gastric cancer, the gastro-oesophageal junction(GEJ) may be involved, but the bulk of the tumour has to be in the stomach; age ≥18 years old, ECOG performance status score ≤2, no prior chemotherapy, TNM stage of T2-T4 or positive regional lymph nodes by endoscopic ultrasound or computed tomography (CT), and adequate hematological, heart, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL).
Key exclusion criteria (1 listed)
- Patients with second malignancies or evidence of severe or uncontrolled systemic disease were excluded.
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 |
|---|---|---|
| mFOLFOX6 regimenoxaliplatin 85 mg/m2 and folinic acid 400 mg/m2 are administered intravenously for 2 hours on day 1 following by 5-FU at 2,400 mg/m2 by continuous infusion for 46hours every 2 weeks for 3 cycles before performing surgery | Drug | mFOLFOX6,chemotherapy regimen |
Primary outcome
The 3-year overall survival rate in patients who will receive mFOLFOX6 regimen as neoadjuvant chemotherapy regimen
Time frame: 3 years
1 secondary outcome
The 3-year disease-free survival rate in the patients who will receive mFOLFOX6 regimen neoadjuvant chemotherapy regimen
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
- Results publication: PubMed 22189752Li ZY, Koh CE, Bu ZD, Wu AW, Zhang LH, Wu XJ, Wu Q, Zong XL, Ren H, Tang L, Zhang XP, Li JY, Hu Y, Shen L, Ji JF. Neoadjuvant chemotherapy with FOLFOX: improved outcomes in Chinese patients with locally advanced gastric cancer. J Surg Oncol. 2012 Jun 15;105(8):793-9. doi: 10.1002/jso.23009. Epub 2011 Dec 20.
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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.
Xiang Wang, Master study director
Department of Medical Oncology Peking Union Medical College 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 mFOLFOX6 regimen in people with Gastric Cancer and Effects of Chemotherapy, run by Peking Union Medical College Hospital at 2 sites in China.
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: status not confirmed, as of the sponsor's last update on 27 Aug 2014. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Wang, Master (+86 (10) 6915 8315, wangxiang5123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 3-year overall survival rate in patients who will receive mFOLFOX6 regimen as neoadjuvant chemotherapy regimen (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02226380, which also lists 1 linked publication.
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 27 Aug 2014.