Stage IV Gastric CancerPhase 2NCT02291211
S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
A Phase 2 study testing S-1 plus cisplatin HIPEC in people with Stage IV Gastric Cancer, run by Tang-Du Hospital at 1 site in China.
Trial summary
This study is designed to investigate the efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy for advanced gastric patients of gastric cytoreductive surgery (CRS) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stage IV Gastric Cancer
- What is being tested?
- S-1 plus cisplatin HIPEC
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Dec 2016
- 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
- 18 ≤ age ≤ 70 years old
- Patients with histologically confirmed gastric cancer (adenocarcinoma), stage IV (limited to the abdominal cavity), accpeted palliative cytoreductive surgery and no prior chemotherapy, biological therapy or targeted anti-cancer therapy, etc.
- The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
- Having given written informed consent prior to any procedure related to the study
- Expected survival time ≥3 months
Who cannot join
- Known to have abdominal viscera metastasis of gastric cancer patients
- Inadequate hematopoietic function which is defined as below:
- white blood cell (WBC) less than 3,500/mm^3
- absolute neutrophil count (ANC) less than 1,500/mm^3
- platelets less than 80,000/mm^3
- Inadequate hepatic or renal function which is defined as below:
Show all 22Show fewer
- serum bilirubin greater than 2 times the upper limit of normal range
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases
- blood creatinine level greater than 1.5 times ULN,Creatinine clearance < 60ml/min
- Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
- Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
- Psychiatric disorder or symptom that makes participation of the patient difficult
- Myocardial infarction, existing serious or unstable angina, and patients with cardiac insufficiency in 6 months
- Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes
- Known DPD deficiency
- Have the history of allograft transplantation
- Conducted the autologous bone marrow transplantation in 4 weeks
- Participate in other clinical trial before the start of this trial in 4 weeks
- Patient compliance is bad or researchers believe that patients are not suitable for this treatment
- Known to have active hepatitis patients
- HER-2-positive patients (ICH3+or FISH+)
- History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University
Xi'an, Shaanxi, 029
Lina Liu, 029-84777631, tangduec@126.com
About this study
Official title: Phase Ⅱ Study of S-1 Combined Cisplatin Hyperthermic Intraperitoneal Chemotherapy for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
This study is designed to investigate the efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy for advanced gastric patients of gastric cytoreductive surgery (CRS)
Read the detailed description
This project is a single-center, open clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept S-1 plus hyperthermic intraperitoneal chemotherapy . With advanced gastric patients of confined to the peritoneal after CRS as the research object, with progression-free survival and overall survival, adverse events as the end points.
- Conditions
- Stage IV Gastric Cancer
- Being tested
- S-1 plus cisplatin HIPEC
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 plus cisplatin HIPECDrug
Also called hyperthermic intraperitoneal chemoperfusion
Using cisplatin in HIPEC plus oral S-1
| Study group | Role | What they receive |
|---|---|---|
| S-1 plus cisplatin HIPEC | Experimental | 8 cycles of hyperthermic intraperitoneal chemotherapy (cisplatin) and S-1(oral) were performed after palliative operation gastric cancer of stage IV limited peritoneal metastasis. HIPEC was conducted in d1 and d3: Normal saline 2000ml-5000ml, Cisplatin 60mg/m^2, 43°C, 60min. every 3 weeks. S-1: 40-60mg/m^2 bid, days 1-14, every 3 weeks.Subjects should be given maximum 8 cycles, or progression/intolerance. Receives: Drug: S-1 plus cisplatin HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS: Progression Free Survival
from randomization to disease progression or death
Measured: 2 years
Secondary outcomes (2)
OS: Overall Survival
from randomization to death from any cause
Measured: 5 years
Safety as measured by recording the subjects' Adverse Events from randomization to termination
Record the subjects' AEs from randomization to termination
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Gastric CancerStudies of the same condition, open and under way.
- More trials run by Tang-Du 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helong Zhang, Professor, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291211
- Sponsor's protocol ID
- TDCCC006
- Status last verified
- Sep 2014
- First submitted
- 11 Nov 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Study of S-1 Combined Cisplatin Hyperthermic Intraperitoneal Chemotherapy for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
- ClinicalTrials.gov ID
- NCT02291211
- Acronym / sponsor ID
- TDCCC006
- Conditions
- Stage IV Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 Nov 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 study is designed to investigate the efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy for advanced gastric patients of gastric cytoreductive surgery (CRS)
Detailed description
This project is a single-center, open clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept S-1 plus hyperthermic intraperitoneal chemotherapy . With advanced gastric patients of confined to the peritoneal after CRS as the research object, with progression-free survival and overall survival, adverse events as the end points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-1 plus cisplatin HIPEC | Experimental | Drug: S-1 plus cisplatin HIPEC8 cycles of hyperthermic intraperitoneal chemotherapy (cisplatin) and S-1(oral) were performed after palliative operation gastric cancer of stage IV limited peritoneal metastasis. HIPEC was conducted in d1 and d3: Normal saline 2000ml-5000ml, Cisplatin 60mg/m^2, 43°C, 60min. every 3 weeks. S-1: 40-60mg/m^2 bid, days 1-14, every 3 weeks.Subjects should be given maximum 8 cycles, or progression/intolerance. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 ≤ age ≤ 70 years old
- Patients with histologically confirmed gastric cancer (adenocarcinoma), stage IV (limited to the abdominal cavity), accpeted palliative cytoreductive surgery and no prior chemotherapy, biological therapy or targeted anti-cancer therapy, etc.
- The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
- Having given written informed consent prior to any procedure related to the study
- Expected survival time ≥3 months
Key exclusion criteria (22 listed)
- Known to have abdominal viscera metastasis of gastric cancer patients
- Inadequate hematopoietic function which is defined as below:
- Inadequate hepatic or renal function which is defined as below:
- Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
- Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
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 |
|---|---|---|
| S-1 plus cisplatin HIPECAlso: hyperthermic intraperitoneal chemoperfusionUsing cisplatin in HIPEC plus oral S-1 | Drug | S-1 plus cisplatin HIPEC |
Primary outcome
PFS: Progression Free Survival
Time frame: 2 years
from randomization to disease progression or death
2 secondary outcomes
OS: Overall Survival
Time frame: 5 years
Safety as measured by recording the subjects' Adverse Events from randomization to termination
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
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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.
Helong Zhang, Professor principal investigator
Tang-Du 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 S-1 plus cisplatin HIPEC in people with Stage IV Gastric Cancer, run by Tang-Du Hospital 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 5 inclusion and 22 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 14 Nov 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 Helong Zhang, Professor (029-87777225, cnxazhl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS: Progression Free Survival (time frame: 2 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 14 Nov 2014.