UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002957 |
|---|---|
| Receipt number | 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 17:19:17 |
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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
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
ykodera@med.nagoya-u.ac.jp
Sponsor or person
Institute
Non profit organization ECRIN
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003407
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