UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	INtraPeritoneal Administration of ChemoTherapeutic agent Trial
Title of the study (Brief title)	INPACT trial
Region	Japan

Condition
Condition	gastric cancer (large type 3 or type 4 cancer, or cancer with CY1 or P1 status who nevertheless will be treated by gastrectomy)
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This randomized phase II study aims to evaluate a chemotherapeutic regimen involving intraperitoneal paclitaxel against scirrhous type gastric cancer and cases with minimal peritoneal deposits or detactable free cancer cells in the peritoneal cavity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	2 year survival rate
Key secondary outcomes	toxicity progression free survival overall survival

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	intraperitoneal paclitaxel administration at 60 mg/m2 on days 0, 14, 21, 28, 42, 49, 56.
Interventions/Control_2	intravenous paclitaxel administration at 80 mg/m2 on days 0, 14, 21, 28, 42, 49, 56.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histological diagnosis of adenocarcinoma of the stomach 2) Macroscopically type 3 or type 4, or are suspected to suffer from peritoneal metastasis 3) Macroscopically type 3 will need to exceed 8 cm in diameter either by the endoscopy or double contrast study 4) No bulky nodal metastasis, hepatic , lung metastasis, massive ascites, thoracic effusion, other distant metastasis by computerized tomography 5) No clinical evidence of distant metastasis 6) Previously untreated by chemotherapy or radiation 7) ECOG Performance statsu 0 or 1 8) adequate organ functions 9) No serious arrhythmia on ECG within 3 months of registration 10) Surgery planned less than 1 month ahead 11) Written informed consent obtained
Key exclusion criteria	1) Serious cardiac, hepatic, and pulmonary comorbidities or uncontrollable diabetes mellitus. Active gastrointestinal bleeding or bowel obstruction 2) Active second malignancy either found simultaneously or within 5 years from the diagnosis of gastric cancer 3) Suffering from infection 4) Under steroid therapy 5) Has wishes to become pregnant 6) Under mental disorder 7) allergy to the ingredients of paclitaxel injection 8) severe drug allergy 9) Peripheral neural disorder
Target sample size	100

Research contact person
Name of lead principal investigator	Yasuhiro Kodera
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Surgery II
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2250
Email	ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person	Yasuhiro Kodera
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Surgery II
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	0525-744-2249
Homepage URL
Email	ykodera@med.nagoya-u.ac.jp

Sponsor
Institute	Non profit organization ECRIN
Institute
Department

Funding Source
Organization	Non profit organization ECRIN
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

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	名古屋大学付属病院（愛知県） 近畿大学付属病院（大阪府） 東京慈恵会医科大学附属柏病院（千葉） 東京慈恵会医科大学附属病院（東京都） 神奈川県立がんセンター（神奈川県） 愛知県がんセンター（愛知県） 千葉県がんセンター（千葉県） 市立伊丹病院（大阪府） 金沢医科大学付属病院（石川県） 兵庫県立淡路病院（兵庫県） 群馬大学医学部付属病院（群馬県） 九州大学付属病院（福岡県）

Other administrative information
Date of disclosure of the study information	2009 Year 12 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 09 Month 01 Day
Anticipated trial start date	2009 Year 10 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2017 Year 09 Month 27 Day
Date trial data considered complete	2017 Year 11 Month 02 Day
Date analysis concluded	2017 Year 12 Month 19 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	Intraperitoneal administration of paclitaxel was safely conducted with minimal adverse events. However, there was no significant difference in progression-free survival and overall survival between the two arms.
Other related information

Management information
Registered date	2009 Year 12 Month 30 Day
Last modified on	2018 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003407