UMIN-CTR Clinical Trial

Basic information
Public title	Peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients
Acronym	GAPS study
Scientific Title	Peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients
Scientific Title:Acronym	GAPS study
Region	Japan

Condition
Condition	serosa positive gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of peri-operative chemotherapy with intraperitoneal and intravenous Paclitaxel plus TS-1 for serosa positive gastric cancer patients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	percent completion of protocol treatment
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	intraperitoneal and intravenous Paclitaxel plus TS-1
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	(i) Histologically proven common gastric carcinoma (ii) Suspected serosa invasive gastric cancer (iii) There must be an absence of peritoneal metastasis or negative finding from peritoneal washing cytology confirmed by staging laparoscopy (iv) The patient must have clinically resectable gastric cancer (v) Tumor invasion of the esophagus must be less than 3 cm, (vi) Patients must be in the age range 20-75 years (vii) The Eastern Cooperative Oncology Group performance status must be 0 or 1 (viii) No previous therapy against GC should have been carried out, and no previous chemotherapy, CRT or radiotherapy (ix) No typical bleeding from GC and stenosis of gastro-intestinal tract should have occurred (x) Sufficient oral intake is required (xi) Written informed consent will be obtained from all patients (xii) Adequate organ functions are required
Key exclusion criteria	(i) The occurrence of simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor that is curable with local therapy (ii) A history of severe drug hypersensitivity (iii) The presence of active bacterial or fungal infection, and a body temperature over 38 temperature. (iv) Pregnancy or lactation in women of childbearing potential (v) Men who wish the partners pregnancy (vi) The presence of unstable angina, heart failure or a history of myocardial infarction within 6 months (vii) Patients requiring systemic steroid medication (viii) Patients requiring the administration of phenytoin or warfarin potassium (ix) The presence to peptic ulcer or bleeding (x) The presence of severe diarrhea (xi) The presence of antigen-positive serum HBs and/or antibody positive serum HVC (xii) The presence of uncontrollable intestinal paralysis, interstitial pneumonitis or ischemic heart disease (xiii) Patients determined to be inappropriate for this study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Motohiro Middle name Last name Imano
Organization	Kinki University Faculty of Medicine
Division name	Department of Surgery
Zip code	5898511
Address	377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
TEL	072-366-0221
Email	imano@med.kindai.ac.jp

Public contact
Name of contact person	1st name Motohiro Middle name Last name Imano
Organization	Kinki University Faculty of Medicine
Division name	Department of Surgery
Zip code	5898511
Address	377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
TEL	072-366-0221
Homepage URL
Email	imano@med.kindai.ac.jp

Sponsor
Institute	Intraperitoneal chemotherapy study group
Institute
Department

Funding Source
Organization	Intraperitoneal chemotherapy study group
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	Kindai University
Address	377-2 Ohno-Higashi, Osaka-Sayama, Osaka 589-8511, Japan
Tel	072-366-0221
Email	imano@med.kindai.ac.jp

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	2014 Year 02 Month 21 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	2014 Year 02 Month 20 Day
Date of IRB	2014 Year 01 Month 08 Day
Anticipated trial start date	2014 Year 05 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 02 Month 08 Day
Last modified on	2022 Year 08 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015292