Stomach NeoplasmsPhase 3SVOSANCT02338518
Comparison of SEEOX and SOX Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients
A Phase 3 study testing oxaliplatin, etoposide and pharmorubicin in people with Stomach Neoplasms and Gastric Cancer, run by Jinling Hospital, China at 1 site in China.
Trial summary
Chemotherapy is an important therapeutic method for patients with advanced gastric cancer. However, there is currently no established standard chemotherapeutic regimen in the preoperative or neoadjuvant treatment setting. The aim of our study was to compare the efficacy and toxicity between SEEOX and SOX regimens. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Stomach Neoplasms, Gastric Cancer
- What is being tested?
- oxaliplatin, etoposide and pharmorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2015to Oct 2023
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group(ECOG) score 0-2
- Ambulatory males or females, aged 30-70 years.
- Unresectable gastric cancer (Tumors with bulky nodal metastases surrounding the celiac artery and its branches or invasion of adjacent structures such as pancreas, omentum, esophagus, and aorta were considered unresectable)
- Life expectancy more than 3 months
- Give written informed consent, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- Normal hepatic, renal, and bone marrow function (GPT<2 fold of upper limit value; white blood cell count>4000/dl, Tbil<1.5mg/dl, Cr<1.5 fold of upper limit value)
Who cannot join
- Patients can not bear surgical procedure.
- Pregnant or lactating women.
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy.
- 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.
- 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.
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- 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.
- With abdominal cavity implantation metastasis or distant metastasis.
- Unwilling or unable to comply with the protocol for the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of SEEOX and SOX Chemotherapeutic Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients
Chemotherapy is an important therapeutic method for patients with advanced gastric cancer. However, there is currently no established standard chemotherapeutic regimen in the preoperative or neoadjuvant treatment setting. The aim of our study was to compare the efficacy and toxicity between SEEOX and SOX regimens. The investigators estimate that combined intravenous and intra-arterial intensified SEEOX preoperative chemotherapy may be a safe and promising regimen for locally advanced or initially unresectable gastric cancer patients.
Read the detailed description
Gastric cancer patients who will receive neoadjuvant chemotherapy would be included in this study. They would receive combined intravenous and intra-arterial intensified SEEOX neoadjuvant chemotherapy or SOX regimen at random. The efficacy and toxicity of these two regimens would be compared.
- Conditions
- Stomach Neoplasms, Gastric Cancer
- Being tested
- oxaliplatin, etoposide, pharmorubicin, S-1
- Keywords
- gastric cancer, neoadjuvant chemotherapy, efficacy, safety
- 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 100 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group and SOX group.
Intravenous oxaliplatin 130 mg/m2 was administered on day 1 of every cycle in SOX group.
etoposideDrug
etoposide 80 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.
pharmorubicinDrug
Also called epirubicin
pharmorubicin 30 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.
S-1Drug
80~120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks in both SEEOX and SOX groups.
| Study group | Role | What they receive |
|---|---|---|
| SEEOX group | Experimental | A three-cycle neo-adjuvant chemotherapy was performed in all cases. In every cycle, oxaliplatin 100 mg/m2, etoposide 80 mg/m2, and pharmorubicin 30 mg/m2 were administered from the celiac artery on day 1. 80～120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks. The second cycle was scheduled following a 1-week rest after the first cycle. Receives: Drug: oxaliplatin; Drug: etoposide; Drug: pharmorubicin; Drug: S-1 |
| SOX group | Active comparator | A three-cycle neo-adjuvant chemotherapy was performed in all cases. In every cycle, patients received intravenous oxaliplatin 130 mg/m2 on day 1, and 80~120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks. The second cycle was scheduled following a 1-week rest after the first cycle. Receives: Drug: oxaliplatin; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year progression free survival
time period calculated from randomization to the first disease progression, recurrence or death from any cause
Measured: up to 7 years
Secondary outcomes (4)
Objective response rate
the proportion of patients with complete and partial response according to Response Evaluation Criteria in Solid Tumors guidelines (version 1.1)
Measured: up to 4 years
R0 resection rate
the proportion of complete tumor resection with no microscopic or macroscopic residual diseases in all operations
Measured: up to 4 years
3 year overall survival
time period calculated from randomization to death from any cause
Measured: up to 7 years
Adverse events of preoperative chemotherapy
preoperative chemotherapy associated complications
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study start4 Jan 2015
- Primary completion21 May 2019
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 297 participants (actual)
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
- NCT02338518
- Sponsor's protocol ID
- 20140621
- Other IDs
- 08Z28
- Acronym
- SVOSA
- Status last verified
- Sep 2023
- First submitted
- 15 Oct 2014
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of SEEOX and SOX Chemotherapeutic Regimens in Stage ⅢB/ⅢC Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT02338518
- Acronym / sponsor ID
- SVOSA / 20140621
- Conditions
- Stomach Neoplasms, Gastric Cancer
- Keywords
- gastric cancer, neoadjuvant chemotherapy, efficacy, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 4 Jan 2015 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- Oct 2023 (estimated)
- First posted
- 14 Jan 2015 (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.
Chemotherapy is an important therapeutic method for patients with advanced gastric cancer. However, there is currently no established standard chemotherapeutic regimen in the preoperative or neoadjuvant treatment setting. The aim of our study was to compare the efficacy and toxicity between SEEOX and SOX regimens. The investigators estimate that combined intravenous and intra-arterial intensified SEEOX preoperative chemotherapy may be a safe and promising regimen for locally advanced or initially unresectable gastric cancer patients.
Detailed description
Gastric cancer patients who will receive neoadjuvant chemotherapy would be included in this study. They would receive combined intravenous and intra-arterial intensified SEEOX neoadjuvant chemotherapy or SOX regimen at random. The efficacy and toxicity of these two regimens would be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEEOX group | Experimental | Drug: oxaliplatin, Drug: etoposide, Drug: pharmorubicin, Drug: S-1A three-cycle neo-adjuvant chemotherapy was performed in all cases. In every cycle, oxaliplatin 100 mg/m2, etoposide 80 mg/m2, and pharmorubicin 30 mg/m2 were administered from the celiac artery on day 1. 80～120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks. The second cycle was scheduled following a 1-week rest after the first cycle. |
| SOX group | Active comparator | Drug: oxaliplatin, Drug: S-1A three-cycle neo-adjuvant chemotherapy was performed in all cases. In every cycle, patients received intravenous oxaliplatin 130 mg/m2 on day 1, and 80~120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks. The second cycle was scheduled following a 1-week rest after the first cycle. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eastern Cooperative Oncology Group(ECOG) score 0-2
- Ambulatory males or females, aged 30-70 years.
- Unresectable gastric cancer (Tumors with bulky nodal metastases surrounding the celiac artery and its branches or invasion of adjacent structures such as pancreas, omentum, esophagus, and aorta were considered unresectable)
- Life expectancy more than 3 months
- Give written informed consent, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Key exclusion criteria (12 listed)
- Patients can not bear surgical procedure.
- Pregnant or lactating women.
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy.
- 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.
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 100 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group and SOX group. Intravenous oxaliplatin 130 mg/m2 was administered on day 1 of every cycle in SOX group. | Drug | SEEOX group, SOX group |
| etoposideetoposide 80 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group. | Drug | SEEOX group |
| pharmorubicinAlso: epirubicinpharmorubicin 30 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group. | Drug | SEEOX group |
| S-180~120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks in both SEEOX and SOX groups. | Drug | SEEOX group, SOX group |
Primary outcome
3 year progression free survival
Time frame: up to 7 years
time period calculated from randomization to the first disease progression, recurrence or death from any cause
4 secondary outcomes
Objective response rate
Time frame: up to 4 years
R0 resection rate
Time frame: up to 4 years
3 year overall survival
Time frame: up to 7 years
Adverse events of preoperative chemotherapy
Time frame: up to 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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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 3 study testing oxaliplatin, etoposide and pharmorubicin 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 6 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 29 Sep 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
3 year progression free survival (time frame: up to 7 years). 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 29 Sep 2023.