Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6 | NCT03618758

Studies
Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6

NCT03618758

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Dec 5, 2023Actual

Enrollment

35Actual

Phase

Phase 1Phase 2

Conditions

Gastric Cancer Stage IV
Peritoneal Carcinomatosis
Intraperitoneal Paclitaxel
mFOLFOX6

Interventions

Paclitaxel
mFOLFOX6 regimen

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 24, 2018Actual

Primary Completion Date

Aug 31, 2023Actual

Completion Date

Dec 2, 2023Actual

First Submitted Date

Aug 2, 2018

First Submission Date that Met QC Criteria

Aug 2, 2018

First Posted Date

Aug 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2023

Last Update Posted Date

Dec 5, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyung-Ho Kim, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Name	Class
Boryung Pharmaceutical Co., Ltd	INDUSTRY
B. Braun Korea Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gastric Cancer with Peritoneal Carcinomatosis	Experimental	Intraperitoneal Chemotherapy (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)	Drug: Paclitaxel Drug: mFOLFOX6 regimen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paclitaxel	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose determination (Phase 1)	Dosage determination of Intraperitoneal Paclitaxel	1 Year
Overall survival (Phase 2)	1 year Overall survival with determined dose from Phase 1	1 Year

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival	1 year Progression-free survival	1 Year
Toxicity ratio	Toxicity occurrence ratio by CTCAE V.4	3 Years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hyung-Ho Kim, M.D., PhD.	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	13620	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D010534	Peritoneal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017239	Paclitaxel
C000708971	genexol-PM

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided