Stomach NeoplasmPhase 1NCT04913662
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
A Phase 1 study testing Pressurized Intraperitoneal Aerosol Chemotherapy in people with Stomach Neoplasm and Peritoneal Metastases, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
This is a phase I trial investigating the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel combined with intravenous FOLFOX therapy for gastric cancer patients with peritoneal metastasis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stomach Neoplasm, Peritoneal Metastases
- What is being tested?
- Pressurized Intraperitoneal Aerosol Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Apr 2021to 30 Jun 2022
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically diagnosed as gastric adenocarcinoma
- Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis
- HER-2 negative tumor
- Laboratory tests adequate for chemotherapy (within 2 weeks of enrollment)
- Absolute Neutrophil Count: ≧ 1,500/mm³
- Hemoglobin level: ≧ 8.0g/dL
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- Platelet Count: ≧ 10×104/mm³
- AST (GOT), ALT (GPT): ≦ 100U/L
- Total Bilirubin: ≦ 2.0mg/dL
- Creatinine Clearance (CCl): ≧ 50mL/min
- ECOG 0 - 2
Who cannot join
- Patients with other major medical disease or malignant tumors other than gastric cancer
- Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel
- Pregnant, breast-feeding women or with birth plan
- History of gastrointestinal surgery
- Patients refusing treatment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
So Hyun Kang, +82-10-7334-7124, shkang@snubh.org
About this study
Official title: Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
This is a phase I trial investigating the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel combined with intravenous FOLFOX therapy for gastric cancer patients with peritoneal metastasis.
- Conditions
- Stomach Neoplasm, Peritoneal Metastases
- Being tested
- Pressurized Intraperitoneal Aerosol Chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressurized Intraperitoneal Aerosol ChemotherapyProcedure or surgery
Aerosolization of chemotherapic agent for intraperitoneal chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| PIPAC Paclitaxel with FOLFOX | Experimental | PIPAC (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin) Receives: Procedure: Pressurized Intraperitoneal Aerosol Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended dose
Recommended dose of paclitaxel for a phase II trial
Measured: Dose-limiting toxicity within 2 weeks after 1st intraoperative PIPAC (each cycle is 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start26 Apr 2021
- Primary completion26 Apr 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospicare Co., Ltd.
- Responsible party
- Principal investigator, Hyung-Ho Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913662
- Sponsor's protocol ID
- SNUBH_PIPAC_PTX
- Status last verified
- Jun 2021
- First submitted
- 26 Apr 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
- ClinicalTrials.gov ID
- NCT04913662
- Acronym / sponsor ID
- SNUBH_PIPAC_PTX
- Conditions
- Stomach Neoplasm, Peritoneal Metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Hospicare Co., Ltd.
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 26 Apr 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 4 Jun 2021 (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 phase I trial investigating the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel combined with intravenous FOLFOX therapy for gastric cancer patients with peritoneal metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PIPAC Paclitaxel with FOLFOX | Experimental | Procedure: Pressurized Intraperitoneal Aerosol ChemotherapyPIPAC (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically diagnosed as gastric adenocarcinoma
- Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis
- HER-2 negative tumor
- Laboratory tests adequate for chemotherapy (within 2 weeks of enrollment)
- Absolute Neutrophil Count: ≧ 1,500/mm³
Key exclusion criteria (5 listed)
- Patients with other major medical disease or malignant tumors other than gastric cancer
- Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel
- Pregnant, breast-feeding women or with birth plan
- History of gastrointestinal surgery
- Patients refusing treatment
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 |
|---|---|---|
| Pressurized Intraperitoneal Aerosol ChemotherapyAerosolization of chemotherapic agent for intraperitoneal chemotherapy | Procedure or surgery | PIPAC Paclitaxel with FOLFOX |
Primary outcome
Recommended dose
Time frame: Dose-limiting toxicity within 2 weeks after 1st intraoperative PIPAC (each cycle is 6 weeks)
Recommended dose of paclitaxel for a phase II trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pressurized Intraperitoneal Aerosol Chemotherapy in people with Stomach Neoplasm and Peritoneal Metastases, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 11 inclusion and 5 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 4 Jun 2021. 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 South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 So Hyun Kang (+82-10-7334-7124, shkang@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended dose (time frame: Dose-limiting toxicity within 2 weeks after 1st intraoperative PIPAC (each cycle is 6 weeks)). 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 4 Jun 2021.