UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study of intraperitoneal paclitaxel combined with mFOLFOX6 for gastric cancer patients with peritoneal metastasis and inadequate oral intake
Acronym	Phase I/II study of FOLFOX+IP PTX
Scientific Title	Exploratory study of intraperitoneal paclitaxel combined with mFOLFOX6 for gastric cancer patients with peritoneal metastasis and inadequate oral intake
Scientific Title:Acronym	Phase I/II study of FOLFOX+IP PTX
Region	Japan

Condition
Condition	gastric cancer with peritoneal metastasis
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of intraperitoneal paclitaxel combined with mFOLFOX6 in gastric cancer patients with peritoneal metastasis and inadequate oral intake
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	1-year overall survival
Key secondary outcomes	progression-free survival time to treatment failure response rate negative conversion rate on peritoneal cytology safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	mFOLFOX6 on days 1 and 15 intraperitoneal paclitaxel on days 1, 8 and 15 in 28days
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) histologically or cytologically proven gastric adenocarcinoma 2) peritoneal metastasis confirmed by diagnostic imaging, staging laparoscopy or laparotomy 3) difficult to be treated with oral anticancer agents due to inadequate oral intake 4) no previous chemotherapy or previous chemotherapy less than one month without disease progression or severe adverse events 5) adequate organ functions(according to the laboratory data which was taken within 14 days before registration) neutrophil count > 1,500/mm3 hemoglobin > 8.0 g/dl platelet count > 100,000/mm3 serum transaminases < 100/UI total serum bilirubin < 2.0mg/dl creatinine clearance > 50mL/min 6) Eastern Cooperative Oncology Group performance status 0-2 7) HER2 negative or unknown 8) an expected survival period of more than 3 months. 9) age between 20 and 80 years 10) written informed consent
Key exclusion criteria	1) metastasis to distant organ sites other than the peritoneum, ovary or abdominal lymph nodes 2) other active concomitant malignancies 3) massive ascites which requires frequent drainage for palliation other severe medical conditions 4) contraindication for fluorouracil, levofolinate, oxaliplatin or paclitaxel 5) past or current severe heart disease 6) severe complications such as interstitial pneumonitis, pulmonary fibrosis, uncontrollable diabetes mellitus, renal failure or liver cirrhosis 7) pregnant or nursing women 8) judged to be unfit to participate in this study by investigators
Target sample size	34

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hironori Ishigami
Organization	The University of Tokyo
Division name	Department of chemotherapy
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	ishigami-tky@umin.net

Public contact
1st name of contact person	1st name Middle name Last name Hironori Ishigami
Organization	The University of Tokyo
Division name	Department of chemotherapy
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	ishigami-tky@umin.net

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 16 Day
Date of IRB	2015 Year 09 Month 17 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2018 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 02 Day
Last modified on	2019 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022204