Stage IV Gastric Cancer With MetastasisNCT03237507
Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer
An observational study of Stage IV Gastric Cancer With Metastasis, run by Harbin Medical University at 1 site in China.
Trial summary
This is a non-interventional study，aim to observe the safety and efficiency of different treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Gastric Cancer With Metastasis
- What is being tested?
- S-1, oxaliplatin and Hyperthermic Intraperitoneal
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 1 Jun 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis
Who may be able to join
- 18 ≤ age
- Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis
- Didn't received any prior systemic chemotherapy
- Signed informed consent
Who cannot join
- History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
- Pregnancy or lactation women,
- Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
- Inadequate organ function which is defined as below:
- Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN); serum creatinine > 1.5 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);
- Symptomatic peripheral neuropathy
Show all 9Show fewer
- Receiving a concomitant treatment with other fluoropyrimidines
- Fluoropyrimidines (DPD) congenital absence
- Other Situations which physicians suggesting are inadaptable for enrollment
Trial locations and contacts
1 site in 1 country.
China1 site
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
About this study
Official title: Prospective and Non-interventional Study on Peritoneal Metastasis of Stage IV Gastric Cancer
This is a non-interventional study，aim to observe the safety and efficiency of different treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world
- Conditions
- Stage IV Gastric Cancer With Metastasis
- Being tested
- S-1, oxaliplatin, Hyperthermic Intraperitoneal, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
40-60mg/m^2 bid, days 1-14, oral，every 3 weeks.
oxaliplatinDrug
100mg/m^2 days 1，intravenous infusion, every 3 weeks.
Hyperthermic IntraperitonealDevice
hyperthermic intraperitoneal chemoperfusion
PaclitaxelDrug
intraperitoneal perfusion
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy Group | chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress Receives: Drug: S-1; Drug: oxaliplatin | |
| Chemotherapy plus HIPEC Group | Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy Receives: Drug: S-1; Drug: oxaliplatin; Device: Hyperthermic Intraperitoneal; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS: Progression Free Survival
time from enrollment to disease progression or death
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
OS:overall survival
time from enrollment to death
Measured: 3 years
Safety
measured by recording the subjects' Adverse Events according to CTCAE 4.03
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 posted2 Aug 2017
- Study start1 Jul 2017
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jun 2020 (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 Cancer With MetastasisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Kuan, M.D.Prof, Harbin Medical University
- Investigators
- Kuan Wang, Principal investigator, Harbin Medical University Cancer Hospital,Gastrointestinal Surgical department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237507
- Sponsor's protocol ID
- TOTPMSG1602
- Status last verified
- Jul 2017
- First submitted
- 31 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Non-interventional Study on Peritoneal Metastasis of Stage IV Gastric Cancer
- ClinicalTrials.gov ID
- NCT03237507
- Acronym / sponsor ID
- TOTPMSG1602
- Conditions
- Stage IV Gastric Cancer With Metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 2 Aug 2017 (actual)
- 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 is a non-interventional study，aim to observe the safety and efficiency of different treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy Group | – | Drug: S-1, Drug: oxaliplatinchemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress |
| Chemotherapy plus HIPEC Group | – | Drug: S-1, Drug: oxaliplatin, Device: Hyperthermic Intraperitoneal, Drug: PaclitaxelHyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis
Key inclusion criteria (4 listed)
- 18 ≤ age
- Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis
- Didn't received any prior systemic chemotherapy
- Signed informed consent
Key exclusion criteria (9 listed)
- History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
- Pregnancy or lactation women,
- Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
- Inadequate organ function which is defined as below:
- Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN); serum creatinine > 1.5 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);
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-140-60mg/m^2 bid, days 1-14, oral，every 3 weeks. | Drug | Chemotherapy Group, Chemotherapy plus HIPEC Group |
| oxaliplatin100mg/m^2 days 1，intravenous infusion, every 3 weeks. | Drug | Chemotherapy Group, Chemotherapy plus HIPEC Group |
| Hyperthermic Intraperitonealhyperthermic intraperitoneal chemoperfusion | Device | Chemotherapy plus HIPEC Group |
| Paclitaxelintraperitoneal perfusion | Drug | Chemotherapy plus HIPEC Group |
Primary outcome
PFS: Progression Free Survival
Time frame: through study completion, an average of 1 year
time from enrollment to disease progression or death
2 secondary outcomes
OS:overall survival
Time frame: 3 years
Safety
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 2 Aug 2017.
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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.
Kuan Wang principal investigator
Harbin Medical University Cancer Hospital,Gastrointestinal Surgical department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage IV Gastric Cancer With Metastasis, run by Harbin Medical University 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 4 inclusion and 9 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 2 Aug 2017. 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.
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?
PFS: Progression Free Survival (time frame: through study completion, an average of 1 year). 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 2 Aug 2017.