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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002957
Receipt No. R000003407
Scientific Title INtraPeritoneal Administration of ChemoTherapeutic agent Trial
Date of disclosure of the study information 2009/12/31
Last modified on 2018/01/05

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Basic information
Public title INtraPeritoneal Administration of ChemoTherapeutic agent Trial
Acronym INPACT trial
Scientific Title INtraPeritoneal Administration of ChemoTherapeutic agent Trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuhiro Kodera
Organization Nagoya University Graduate School of Medicine
Division name Department of Surgery II
Zip code
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
1st name
Middle name
Last name Yasuhiro Kodera
Organization Nagoya University Graduate School of Medicine
Division name Department of Surgery II
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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. 
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
2009 Year 09 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000003407

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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