DSFPhase 2NCT02269904
Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.
A Phase 2 study testing Fluorouracil Implants and Xelox regimes in people with DSF, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is a post-marketing study. The subjects will be divided into two groups (Group A and Group B ). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- DSF
- What is being tested?
- Fluorouracil Implants and Xelox regimes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Jun 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary gastric cancer, Phase III
- D2 radical gastrectomy(R0)
- 18 year old or above
- KPS≥70%；
- suitable hematologic function: ANC≥1.5×109/L, PLC≥80×109/L
- suitable liver function: Total bilirubin≤1.5×normal ULN, AST and ALT≤2.5×normal ULN.
- suitable renal function: Cr≤1.5×normal ULN,or Ccr≥50 ml/min 8 .for the female subject, pregnancy test must be negative in 27 hours before enrollment .
- 9. the authorized ICF must be signed
Who cannot join
- non-initial gastric cancer；
- having the other uncontrolled diseases.
- obvious loss of weight ( more than 10% within 6 weeks )
- the female in pregnancy or feeding.
- contraindication to study drug
- participating in other clinical trial and at the time of treatment period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Heilongjiang Cancer Hospital
Harebin, Heilongjiang, 150000
Chunfeng Li, Doctor, 18745787187, lichunfeng007@163.com
Yingwei Xue, Doctor
About this study
Official title: Fluorouracil Implants（SinoFuan®）Used for Intraperitoneal Chemotherapy During Operation for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer, Randomized, Controlled, Multicentres Open Study.
SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is a post-marketing study. The subjects will be divided into two groups (Group A and Group B ). The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and 6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from SinoFuan will be analyzed through comparing 3 years DFS of two groups.
- Conditions
- DSF
- Being tested
- Fluorouracil Implants, Xelox regimes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorouracil ImplantsDrug
Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.
Xelox regimesDrug
Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.
| Study group | Role | What they receive |
|---|---|---|
| Fluorouracil Implants and Xelox regimes | Active comparator | Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.
Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished. Receives: Drug: Fluorouracil Implants; Drug: Xelox regimes |
| Xelox regimes | Active comparator | Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished. Receives: Drug: Xelox regimes |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS (Disease Free Survival)
During 3 years of monitoring period, any cancer relapse will be recorded
Measured: 3 year
Secondary outcomes (1)
adverse event
During 3 years of monitoring period, any AEs will be recorded
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2018 (estimated)
- Study completionJun 2018 (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 DSFStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269904
- Sponsor's protocol ID
- Sinofuan01
- Status last verified
- Oct 2014
- First submitted
- 17 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Xu Y, Zhang R, Li C, Sun Z, Deng J, Wang X, Ding X, Wang B, Xue Q, Ke B, Zhan H, Liu N, Liu Y, Wang X, Liang H, Xue Y, Xu H. Intraperitoneal Chemotherapy Using Fluorouracil Implants Combined With Radical Resection and Postoperative Adjuvant Chemotherapy for Stage III Gastric Cancer: A Multi-Center, Randomized, Open-Label, Controlled Clinical Study. Front Oncol. 2021 Jul 8;11:670651. doi: 10.3389/fonc.2021.670651. eCollection 2021.
PubMed 34307140
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorouracil Implants（SinoFuan®）Used for Intraperitoneal Chemotherapy During Operation for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer, Randomized, Controlled, Multicentres Open Study.
- ClinicalTrials.gov ID
- NCT02269904
- Acronym / sponsor ID
- Sinofuan01
- Conditions
- DSF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 21 Oct 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.
SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is a post-marketing study. The subjects will be divided into two groups (Group A and Group B ). The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and 6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from SinoFuan will be analyzed through comparing 3 years DFS of two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluorouracil Implants and Xelox regimes | Active comparator | Drug: Fluorouracil Implants, Drug: Xelox regimesFluorouracil Implants: 800mg, implanted in the abdominal cavity during operation. Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished. |
| Xelox regimes | Active comparator | Drug: Xelox regimesXelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- primary gastric cancer, Phase III
- D2 radical gastrectomy(R0)
- 18 year old or above
- KPS≥70%；
- suitable hematologic function: ANC≥1.5×109/L, PLC≥80×109/L
Key exclusion criteria (6 listed)
- non-initial gastric cancer；
- having the other uncontrolled diseases.
- obvious loss of weight ( more than 10% within 6 weeks )
- the female in pregnancy or feeding.
- contraindication to study drug
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 |
|---|---|---|
| Fluorouracil ImplantsFluorouracil Implants: 800mg, implanted in the abdominal cavity during operation. | Drug | Fluorouracil Implants and Xelox regimes |
| Xelox regimesXelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished. | Drug | Fluorouracil Implants and Xelox regimes, Xelox regimes |
Primary outcome
DFS (Disease Free Survival)
Time frame: 3 year
During 3 years of monitoring period, any cancer relapse will be recorded
1 secondary outcome
adverse event
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
- Derived from this study: PubMed 34307140Xu Y, Zhang R, Li C, Sun Z, Deng J, Wang X, Ding X, Wang B, Xue Q, Ke B, Zhan H, Liu N, Liu Y, Wang X, Liang H, Xue Y, Xu H. Intraperitoneal Chemotherapy Using Fluorouracil Implants Combined With Radical Resection and Postoperative Adjuvant Chemotherapy for Stage III Gastric Cancer: A Multi-Center, Randomized, Open-Label, Controlled Clinical Study. Front Oncol. 2021 Jul 8;11:670651. doi: 10.3389/fonc.2021.670651. eCollection 2021.
Related trials for DSF
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.
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 Fluorouracil Implants and Xelox regimes in people with DSF, run by Jiangsu Simcere Pharmaceutical Co., Ltd. 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 6 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 21 Oct 2014. 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 Yan Xu, Doctor (13204032770, xyab@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (Disease Free Survival) (time frame: 3 year). 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 NCT02269904, 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 21 Oct 2014.