UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of neoadjuvant chemotherapy with S-1 and oxaliplatin followed by surgery in cStageIII advanced gastric cancer patients
Title of the study (Brief title)	A phase II study of neoadjuvant chemotherapy with S-1 and oxaliplatin followed by surgery in cStageIII advanced gastric cancer patients
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of the safety and efficacy of perioperative SOX therapy in cStageIII advanced gastric cancer patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Percent completion of the protocol treatment
Key secondary outcomes	Overall survival, Relapse-Free Survival, Time to Treatment Failure, Percent completion of neoadjuvant chemotherapy, Percent completion of adjuvant chemotherapy, Response Rate, Pathological response rate, Incidence of adverse events on neoadjuvant chemotherapy, Incidence of a postoperative complication, The rate of R0 resection, Percent completion of the protocol treatment in patients with over 75 years of age

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 Maneuver
Interventions/Control_1	S-1:80-120mg/body/day,PO,day1-14,Oxaliplatin130 mg/m2, IV day1, every 21 days for 3 cycles followed by surgery (laparoscopic or open gastrectomy, D2 lymph node dissection).Adjuvant chemotherapy(S-1) for one year after surgery.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically proven gastric adenocarcinoma 2) Clinical Stage III gastric cancer 3) Age between 20 and 80 years old 4) ECOG performance status of 0 or 1 5) No previous chemotherapy,radiation therapy or surgery for gastric cancer 6) Adequate organ function 1. WBC:>=3,000/mm3,<12,000/mm3 2. Neutrophil:>=1,500/mm3 3. Platelet:>=100,000/mm3 4. Hemoglobin:>=9.0g/dL 5. AST(GOT)/ALT(GPT):<=100 IU/L 6. Total bilirubin:<=2.0mg/dL 7. Serum creatinine:<=1.2mg 8. Creatinine clearance:>=60 mL/min 7) Possible oral intake 8) Written informed consent from patient
Key exclusion criteria	1) With active double or multiple cancers 2) Severe complications 3) With active infection 4) Positive HBs antigen or positive HCV antibody 5) Continuous systemic steroid therapy 6) Severe diarrhea 7) Past history of severe hypersensitivity to drugs 8) Under treatment with flucytosine 9) Under treatment with warfarin 10) Pregnant women, or women with the possibility of the pregnancy, Men who want let to pregnancy 11) Patients judged inappropriate for the study by the physicians
Target sample size	48

Research contact person
Name of lead principal investigator	Masaki Nakamura
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama
TEL	073-441-0613
Email	twins@wakayama-med.ac.jp

Public contact
Name of contact person	Masaki Nakamura
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1 Kimiidera, Wakayama
TEL	073-441-0613
Homepage URL
Email	twins@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University, Second Department of Surgery
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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 31 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 19 Day
Anticipated trial start date	2016 Year 03 Month 23 Day
Last follow-up date	2023 Year 01 Month 31 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	2016 Year 07 Month 30 Day
Last modified on	2016 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026966