UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)
Acronym	A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)
Scientific Title	A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)
Scientific Title:Acronym	A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)
Region	Japan

Condition
Condition	large type 3 or type 4 gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the efficacy and safety of preoperative TS-1+CDDP+DTX therapy (DCS therapy) and followed curative surgical operation for large type 3 or type 4 gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	incidence of curative resection (R0 ratio)
Key secondary outcomes	Preoperative treatment completion rate Postoperative treatment completion rate Disease Free Survival Overall Survival (OS) Response Rate of preoperative chemotherapy (RECIST v 1.1) Histological Response Rate of preoperative Chemotherapy AE rate of preoperative chemotherapy Incidence of postoperative adverse events

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	It takes four weeks for one course of DCS therapy (DTX 40 mg/m2 iv day 1, CDDP 60 mg/m2 iv day 1 and TS-1 80-120 mg/body day 1-14, followed by 2 weeks rest) Standard treatment is two or three courses before surgical operation Patients undergo surgical operation within 42 days of completion of 2-3 courses After R0 surgical operation, one year TS-1 administration is followed.
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	1)histologically proven gastric carcinoma by endoscopic detection 2)Macroscopic finding is type 4 or type 3 whose size is over 8 cm by endoscopy and/or CT within 28 days before registration 3)Without any P2, P3, liver metastases and/or paraaortic node metastases by CT, PET and/or laparoscopic detection within 28 days before registration 4)Without esophageal invasion longer than 3 cm by endoscopic detection within 28 days before registration 5)Age older than 20 years and younger than 75 years 6)Performance Status(ECOG): 0 or 1 7)Without any history of chemotherapy, radiation therapy and/or surgical operation for the gastric cancer 8)with good functions of important organs by a data taken within 2 weeks of registration a) WBC: =>4000/mm3 and <12,000 mm3 b) Neutrophil: =>1,500/mm3 c) Hemoglobin: =>8.0 g/dl d) Platelet: =>100,000/mm3 e) AST: =< 100 IU/L f) ALT: =< 100 IU/L g) T.bil.: =<1.5 mg/dL h) s-cleatinine: =<1.2mg/dL i) creatinine clearance: =>60 ml/min/body CC by Cockcroft-Gault method is available: => 60mL/min 9)enough oral intake 10)with written Informed Consent
Key exclusion criteria	1)with active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period 2)with a history of severe allergic reaction against medicines 3)with active infectious diseases (over 38 centigrade of body temperature) 4)pregnant or nursing female 5)male expecting pregnancy of partner 6)with a history of cardiac infarction within 6 months 7)under continuous steroids medication 8)under continuous medication of phenytoin or warfarin 9)with uncontrollable diarrhea (frequent movement and/or watery stool) 10)with HBs antigen positive or HCV antibody positive 11)With severe diseases (collagen disease, intestinal paralysis, interstitial pneumonitis, and/or ischemic cardiac disease) 12)Any other patients whom the physician in charge of the study judges to be unsuitable
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazumasa Fujitani
Organization	Osaka General Medical Center
Division name	Department of Surgery
Zip code
Address	3-1-56, Bandaihigashi, Sumiyosi-ku, Osaka-City, 558-8558, Japan
TEL	06-6692-1201
Email	fujitani@gh.opho.jp

Public contact
Name of contact person	1st name Middle name Last name Jyunji Kawada
Organization	Kaizuka City Hospital
Division name	Department of Surgery
Zip code
Address	3-10-20, Hori, Kaizuka-City, Osaka Prefecture, 597-0015, Japan
TEL	072-422-5865
Homepage URL
Email	j-kawada@umin.ac.jp

Sponsor
Institute	Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization	Osaka Clinical Study Supporting Organization
Organization
Division
Category of Funding Organization	Self funding
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	(OGSG 参加施設) 大阪医科大学(大阪府)、大阪労災病院(大阪府)、市立貝塚病院(大阪府)、大阪急性期･総合医療センター(大阪府)、市立池田病院(大阪府)、箕面市立病院(大阪府)、市立豊中病院(大阪府)、北野病院(大阪府)、関西労災病院(兵庫県)、関西電力病院(大阪府)、八尾市立病院(大阪府)、市立東大阪医療センター（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 10 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	48
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 10 Month 04 Day
Date of IRB	2014 Year 11 Month 26 Day
Anticipated trial start date	2015 Year 03 Month 16 Day
Last follow-up date	2021 Year 06 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 09 Month 27 Day

Other
Other related information	Registered with JRCT on 26/03/2019 Certification number: CRB5200005 Trial ID: jRCTs051180195

Management information
Registered date	2014 Year 11 Month 07 Day
Last modified on	2021 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018147