Stomach NeoplasmsPhase 2NCT-B4NCT02949258
Neoadjuvant Chemotherapy With SEEOX Regimen for Borrmann Type 4 Gastric Cancer
A Phase 2 study testing oxaliplatin, etoposide and epirubicin in people with Stomach Neoplasms and Gastric Cancer, run by Jinling Hospital, China at 1 site in China.
Trial summary
Scirrhous gastric cancer, also known as linitis plastic or Borrmann type 4, is an aggressive tumor with an extremely poor prognosis. Aggressive surgical procedures and adjuvant chemotherapies have not improved the survival rate. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Stomach Neoplasms, Gastric Cancer
- What is being tested?
- oxaliplatin, etoposide and epirubicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Jan 2021
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed gastric adenocarcinoma;
- males or females, aged 30-70 years;
- gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (without definitive ulceration) that invaded more than half of the stomach;
- no peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
- eastern Cooperative Oncology Group performance status of 0 or 1;
- no serious concomitant diseases that make survival period < 3 years;
- no prior anti-tumor therapy;
- have signed informed consent before the beginning of treatment.
Who cannot join
- patients can not bear surgical procedure;
- pregnant or lactating women;
- previous cytotoxic chemotherapy, radiotherapy or immunotherapy;
- with peritoneal metastasis or distant metastasis;
- history of another malignancy within the last five years;
- history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake;
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- clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months;
- organ allografts requiring immunosuppressive therapy;
- serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease;
- moderate or severe renal impairment: serum creatinine > 1.5 x upper limit of normal (ULN);
- hypersensitivity to any drug of the study regimen;
- unwilling or unable to comply with the protocol for the duration of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Research institue of general surgery, Jinling hospital
Nanjing, Jiangsu, 210000
Guoli Li, M.D., +86-13851559752
About this study
Official title: A Phase II Study of Neoadjuvant Chemotherapy With SEEOX Regimen Via Intra-arterial and Intravenous Administration Followed by Surgery for Borrmann Type 4 Gastric Cancer
Scirrhous gastric cancer, also known as linitis plastic or Borrmann type 4, is an aggressive tumor with an extremely poor prognosis. Aggressive surgical procedures and adjuvant chemotherapies have not improved the survival rate. The purpose of this study is to determine whether neoadjuvant Chemotherapy with SEEOX regimen via intra-arterial and intravenous administration are effective in the treatment of Borrmann type 4 gastric cancer.
Read the detailed description
Gastric cancer patients who diagnosed as Borrmann type 4 would be included in this study.They would receive 3 cycles of neoadjuvant chemotherapy with SEEOX regimen via combined intra-arterial and intravenous administration. The treatment schedule consisted of 3 courses (each, 2-week administration and 1-week withdrawal) of intra-arterial administration of oxaliplatin (150mg), etoposide (100mg) and epirubicin(30mg) by Seldinger method on day 1 and oral S-1(120mg) on days 1-14, followed by radical surgery.The efficacy and toxicity of SEEOX regimen would be examined.
- Conditions
- Stomach Neoplasms, Gastric Cancer
- Being tested
- oxaliplatin, etoposide, epirubicin, S1
- Keywords
- gastric cancer, Borrmann type 4, Neoadjuvant chemotherapy, Intra-arterial administration
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
oxaliplatin 150 mg will be administered from the celiac artery on day 1 of every cycle in all cases
etoposideDrug
etoposide 100 mg will be administered from the celiac artery on day 1 of every cycle in all cases
epirubicinDrug
epirubicin 30 mg will be administered from the celiac artery on day 1 of every cycle in all cases
S1Drug
Oral S-1 120 mg per day will be administered on days 1-14 of every cycle in all cases
| Study group | Role | What they receive |
|---|---|---|
| SEEOX group | Experimental | A three-cycle neoadjuvant chemotherapy will be performed in all cases. In every cycle, oxaliplatin 150 mg, etoposide 100 mg and epirubicin 50 mg will be administered from the celiac artery on day 1. Oral S-1 120 mg per day will be given for days 1-14. The second cycle will be scheduled following a 1-week rest after the first cycle.After two courses of neoadjuvant chemotherapy, patients will be reevaluated and receive curative or palliative resection or exploratory laparotomy within 14 days after completing the second course of chemotherapy. Receives: Drug: oxaliplatin; Drug: etoposide; Drug: epirubicin; Drug: S1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year survival rate
Measured: up to 4 years
Secondary outcomes (4)
Overall response rate
Measured: up to 2 years
R0 resection rate
Measured: up to 2 years
Operative mortality rate
Measured: up to 2 years
in-hospital mortality rate
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 2021 (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 Stomach NeoplasmsStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Guoli, Jinling Hospital, China
- Investigators
- Guoli Li, M.D., Study chair, Jinlin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949258
- Sponsor's protocol ID
- B4-2016-LGL
- Acronym
- NCT-B4
- Status last verified
- Oct 2016
- First submitted
- 27 Oct 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Xiang XS, Su Y, Li GL, Ma L, Zhou CS, Ma RF. Phase II Study of Preoperative Intra-Arterial Epirubicin, Etoposide, and Oxaliplatin Combined with Oral S-1 Chemotherapy for the Treatment of Borrmann Type 4 Gastric Cancer. J Gastric Cancer. 2020 Dec;20(4):395-407. doi: 10.5230/jgc.2020.20.e40. Epub 2020 Dec 29.
PubMed 33425441
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Chemotherapy With SEEOX Regimen Via Intra-arterial and Intravenous Administration Followed by Surgery for Borrmann Type 4 Gastric Cancer
- ClinicalTrials.gov ID
- NCT02949258
- Acronym / sponsor ID
- NCT-B4 / B4-2016-LGL
- Conditions
- Stomach Neoplasms, Gastric Cancer
- Keywords
- gastric cancer, Borrmann type 4, Neoadjuvant chemotherapy, Intra-arterial administration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 31 Oct 2016 (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.
Scirrhous gastric cancer, also known as linitis plastic or Borrmann type 4, is an aggressive tumor with an extremely poor prognosis. Aggressive surgical procedures and adjuvant chemotherapies have not improved the survival rate. The purpose of this study is to determine whether neoadjuvant Chemotherapy with SEEOX regimen via intra-arterial and intravenous administration are effective in the treatment of Borrmann type 4 gastric cancer.
Detailed description
Gastric cancer patients who diagnosed as Borrmann type 4 would be included in this study.They would receive 3 cycles of neoadjuvant chemotherapy with SEEOX regimen via combined intra-arterial and intravenous administration. The treatment schedule consisted of 3 courses (each, 2-week administration and 1-week withdrawal) of intra-arterial administration of oxaliplatin (150mg), etoposide (100mg) and epirubicin(30mg) by Seldinger method on day 1 and oral S-1(120mg) on days 1-14, followed by radical surgery.The efficacy and toxicity of SEEOX regimen would be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEEOX group | Experimental | Drug: oxaliplatin, Drug: etoposide, Drug: epirubicin, Drug: S1A three-cycle neoadjuvant chemotherapy will be performed in all cases. In every cycle, oxaliplatin 150 mg, etoposide 100 mg and epirubicin 50 mg will be administered from the celiac artery on day 1. Oral S-1 120 mg per day will be given for days 1-14. The second cycle will be scheduled following a 1-week rest after the first cycle.After two courses of neoadjuvant chemotherapy, patients will be reevaluated and receive curative or palliative resection or exploratory laparotomy within 14 days after completing the second course of chemotherapy. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- histologically confirmed gastric adenocarcinoma;
- males or females, aged 30-70 years;
- gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (without definitive ulceration) that invaded more than half of the stomach;
- no peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
- eastern Cooperative Oncology Group performance status of 0 or 1;
Key exclusion criteria (12 listed)
- patients can not bear surgical procedure;
- pregnant or lactating women;
- previous cytotoxic chemotherapy, radiotherapy or immunotherapy;
- with peritoneal metastasis or distant metastasis;
- history of another malignancy within the last five years;
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 |
|---|---|---|
| oxaliplatinoxaliplatin 150 mg will be administered from the celiac artery on day 1 of every cycle in all cases | Drug | SEEOX group |
| etoposideetoposide 100 mg will be administered from the celiac artery on day 1 of every cycle in all cases | Drug | SEEOX group |
| epirubicinepirubicin 30 mg will be administered from the celiac artery on day 1 of every cycle in all cases | Drug | SEEOX group |
| S1Oral S-1 120 mg per day will be administered on days 1-14 of every cycle in all cases | Drug | SEEOX group |
Primary outcome
2-year survival rate
Time frame: up to 4 years
4 secondary outcomes
Overall response rate
Time frame: up to 2 years
R0 resection rate
Time frame: up to 2 years
Operative mortality rate
Time frame: up to 2 years
in-hospital mortality rate
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Derived from this study: PubMed 33425441Xiang XS, Su Y, Li GL, Ma L, Zhou CS, Ma RF. Phase II Study of Preoperative Intra-Arterial Epirubicin, Etoposide, and Oxaliplatin Combined with Oral S-1 Chemotherapy for the Treatment of Borrmann Type 4 Gastric Cancer. J Gastric Cancer. 2020 Dec;20(4):395-407. doi: 10.5230/jgc.2020.20.e40. Epub 2020 Dec 29.
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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.
Guoli Li, M.D. study chair
Jinlin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxaliplatin, etoposide and epirubicin in people with Stomach Neoplasms and Gastric Cancer, run by Jinling Hospital, China at 1 site 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 8 inclusion and 12 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 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Qi He, M.D., PhD. (+86-13851490577, 241549864@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year survival rate (time frame: up to 4 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 NCT02949258, 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 31 Oct 2016.