UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II study of neoadjuvant combination chemotherapy with TS-1, cisplatin and Paclitaxel (PCS) for resectable advanced gastric cancer.
Title of the study (Brief title)	NECESSIT study
Region	Japan

Condition
Condition	resectable advanced gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and tolerability of combination chemotherapy with TS-1, Cisplatin and Paclitaxel in resectable advanced gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	response rate
Key secondary outcomes	pathological complete response rate recurrence-free survival time progression-free survival overall survival proportion of transit surgery proportion of R0 resection Accomplishment rate down stage rate frequency and grade of adverse postoperative complication frequency and grade of adverse event

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	TS-1 administered for 14 days followed by 7 days rest according to body surface area. Cisplatin is administered intravenously in dosage of level at day 1 and day 8. Paclitaxel is administered intravenously in dosage of level at day 1 and day 8.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histopathological confirmation of Adenocarcinoma 2) resectable advanced gastric cancer 3) measurable disease 4) Age over 20 5) ECOG performance status of 0 to 2 6) Sufficient function of important organs Leu : &#8805; 500 /mm3 and&#8804;12,000 /mm3 Neu : &#8805; 2,000 /mm3 Plate : &#8805; 100,000 /mm3 hemoglobin : &#8805; 9.0 g/dL AST, ALT : <100 IU/L St.bil : < 1.5 mg/dL Ccr : &#8805;60 ml/min 7) Ability to ingestion intake and drug administration orally. 8) Informed consent is obtained.
Key exclusion criteria	1) With severe allergy to TS-1, Cisplatin and Paclitaxel 2) Women who are pregnant or breastfeeding. 3) Men who are unwilling to avoid pregnancy. 4) Active infection and inflammation. 5) History of cardiac disease 6) Dyspnea at rest
Target sample size	20

Research contact person
Name of lead principal investigator	Motohiro Imano
Organization	Kinki University Faculty of Medicine
Division name	Department of Surgery
Address	377-2 Ohnohigashi, Osakasayama Osaka
TEL	072-366-0221
Email	imano@med.kindai.ac.jp

Public contact
Name of contact person	Motohiro Imano
Organization	Kinki University Faculty of Medicine
Division name	Department of Surgery
Address	377-2 Ohnohigashi, Osakasayama Osaka
TEL	072-366-022
Homepage URL
Email	imano@med.kindai.ac.jp

Sponsor
Institute	Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	近畿大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2011 Year 11 Month 08 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 04 Month 01 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2022 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 11 Month 05 Day
Last modified on	2017 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007825