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Gastric Cancer Stage IVPhase 1/2IPLUSNCT03618758

Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6

A Phase 1/2 study testing Paclitaxel and mFOLFOX6 regimen in people with Gastric Cancer Stage IV and Peritoneal Carcinomatosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy. Read more about this study

Who is it for?
Ages 20 to 79 years
What is being tested?
Paclitaxel and mFOLFOX6 regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteSouth Korea
Study dates
24 Dec 2018to 2 Dec 2023
Phase
Phase 1/2
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 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy proven adenocarcinoma of gastric origin, primary or recurrent
  • Identification of Peritoneal seeding by CT or diagnostic laparoscopy
  • Patients confirmed to receive mFOLFOX6 on multidisciplinary outpatient clinic
  • No previous history of chemotherapy or 4week after the last chemotherapy for gastric cancer
  • Labs adequate for chemotherapy (within 2 weeks of enrollment)
  • Absolute Neutrophil Count: ≧ 1,500/mm³
Show all 15Show fewer
  • Hemoglobin level: ≧ 8.0g/dL
  • Platelet Count: ≧ 10×104/mm³
  • AST (GOT), ALT (GPT): ≦ 100U/L
  • Total Bilirubin: ≦ 2.0mg/dL
  • Creatinine Clearance (CCl): ≧ 50mL/min
  • ECOG 0 - 2
  • Her-2 negative on endoscopic biopsy
  • Age ≧ 20, < 80
  • Signed Informed consent form

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
  • Patients refusing treatment

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

Other trials in South Korea

About this study

Official title: Safety and Efficacy of Intraperitoneal Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis Receiving Systemic Chemotherapy

Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy. Intraperitoneal chemotherapy in combination with systemic chemotherapy is under many clinical trials mainly in Japan, and are showing promising results.

This is Korea's first clinical trial on Intraperitoneal Paclitaxel with Systemic mFOLFOX6 chemotherapy.

Being tested
Paclitaxel, mFOLFOX6 regimen
Keywords
Gastric cancer, Peritoneal carcinomatosis, Intraperitoneal chemotherapy, Paclitaxel, FOLFOX
Medical subject headings
Stomach Neoplasms, Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called (Genexol®)

    Intraperitoneal application of Paclitaxel Phase 1: Dose determination of Paclitaxel (Recommended Dose) Starting from 40mg/m² upto 100mg/m² maximum

    Phase 2: Intraperitoneal Paclitaxel with recommended dose

  • mFOLFOX6 regimenDrug

    Systemic mFOLFOX6: 5-FU(2400mg/m²), Oxaliplatin(100mg/m²), Leucovorin(100mg/m²)

Study groups in NCT03618758
Study groupRoleWhat they receive
Gastric Cancer with Peritoneal CarcinomatosisExperimentalIntraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)
Receives: Drug: Paclitaxel; Drug: mFOLFOX6 regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose determination (Phase 1)

    Dosage determination of Intraperitoneal Paclitaxel

    Measured: 1 Year

  2. Overall survival (Phase 2)

    1 year Overall survival with determined dose from Phase 1

    Measured: 1 Year

Secondary outcomes (4)

  1. Progression-free survival

    1 year Progression-free survival

    Measured: 1 Year

  2. Toxicity ratio

    Toxicity occurrence ratio by CTCAE V.4

    Measured: 3 Years

  3. Tumor response

    Tumor response with RECIST criteria V.1.1 and Peritoneal Regression Grading Score(PRGS) system

    Measured: 3 Years

  4. Conversion surgery ratio

    Conversion surgery after stable disease or regression

    Measured: 3 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2018
  2. Study start24 Dec 2018
  3. Primary completion31 Aug 2023
  4. Study completion2 Dec 2023

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03618758
Sponsor's protocol ID
SNUBH_GS_IPEC
Acronym
IPLUS
Status last verified
Dec 2023
First submitted
2 Aug 2018
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Paclitaxel and mFOLFOX6 regimen in people with Gastric Cancer Stage IV and Peritoneal Carcinomatosis, 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 15 inclusion and 4 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: finished, as of the sponsor's last update on 5 Dec 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 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 combined 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.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Dose determination (Phase 1) (time frame: 1 Year). The study lists 2 primary outcomes in all. 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 NCT03618758.

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 5 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.

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