UMIN-CTR Clinical Trial

Basic information
Public title	Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601)
Acronym	Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601)
Scientific Title	Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601)
Scientific Title:Acronym	Perioperative CapeOx therapy for clinical stage III gastric cancer; a phase II study (OGSG1601)
Region	Japan

Condition
Condition	Gastric Cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Eevaluate the efficacy of perioperative CapeOx therapy in patients with clinical stage III gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	pathological response rate
Key secondary outcomes	1.Percent completion (PC) of the protocol treatment 2.Relative Dose Intensity (RDI) of neoadjuvant chemotherapy 3.Percent completion of adjuvant chemotherapy 4.Overall survival 5.Relapse free survival 6.Response Rate (RR) 7.Incidence of adverse events on neoadjuvant chemotherapy 8.Incidence of a postoperative complication 9.Relative Dose Intensity(RDI) of adjuvant chemotherapy

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 Other
Interventions/Control_1	preoperative CapeOx therapy Capecitabine : 1,000mg/m2 bid, day1-14, q3w Oxaliplatin : 130mg/m2, day 1, q3w 3 cycle Surgery Postoperative CapeOx therapy Capecitabine : 1,000mg/m2 bid, day1-14, q3w Oxaliplatin : 130mg/m2, day 1, q3w 5 cycle
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) Histologically proven gastric adenocarcinoma 2) Clinically diagnosed cSS/SE N1-3 MO gastric cancer 3) Aged 20 years old or over 4) ECOG performance status of 0 or 1 5) Possible oral intake 6) Adequate organ function a. neutrophilic count : => 1500/mm3 b. hemoglobin : => 8g/dL c. platelet : => 100,000/mm3 d. AST, ALT : =< 100 IU/L e. total bilirubin : =< 2mg/dL f. creatinine clearance : => 50mL/min 7) Wrriten informed consent from patient
Key exclusion criteria	1) With active double cancers 2) Past history of severe hypersensitivity to drugs 3) With active infection 4) Pregnant women, or women with the possibility of the pregnancy 5) Men who want let to pregnancy 6) History of myocardial infarction within 6 months 7) Continuous systemic steroid therapy 8) Under treatment with flucytosine, phenytoin 9) Severe diarrhea 10) Positive HBs antigen 11) Severe complications 12) Bulky lymph node metastasis, Borrmann type 4 or large type 3 13) Patients juged inappropriate for the study by the physicians
Target sample size	37

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahiro Gotou
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Center
Zip code
Address	2-7 Daigaku-machi, Takatsuki City , Osaka, 569-8686
TEL	072-683-1211
Email	in2030@poh.osaka-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tetsuji Terazawa
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Center
Zip code
Address	2-7 Daigaku-cho, Takatsuki, Osaka, 569-8686
TEL	072-683-1211
Homepage URL
Email	terasawat@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization	Yakult Honsha Co.,Ltd
Organization
Division
Category of Funding Organization	Profit organization
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	大阪医科大学（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 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	37
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	No longer recruiting
Date of protocol fixation	2016 Year 02 Month 05 Day
Date of IRB	2016 Year 03 Month 07 Day
Anticipated trial start date	2016 Year 07 Month 07 Day
Last follow-up date	2020 Year 07 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 27 Day
Last modified on	2020 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024899

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.