UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Docetaxel, Cisplatin and S1 followed by surgery in advanced gastric cancer with lymph node metastasis of the paraaorta
Title of the study (Brief title)	Paraaorta GC preoperative DCS Phase II
Region	Japan

Condition
Condition	gastric cancer with para-aortic lymph node metastasis
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the safty and efficacy of Docetaxel+CDDP+S-1 as preoperative chemotherapy for gastric carcinoma in patients with para-aortic lymph node metastasis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	histological response of para-aortic lymph node in preoperative chemotherapy
Key secondary outcomes	proportion of completion of treatment, proportion of curative resection, response rate(RECISTv.1.0), 3-year survival, proportion of toxicities, proportion of treatment related death

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 Maneuver
Interventions/Control_1	Preoperative chemotherapy with Docetalxel+CDDP+S-1 followed by gastrectomy with D2 and para-aortic nodal dissection
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 2) Para-aortic lymph node metastassis which was more than 10mm in diameter by contrast enhanced CT 3) None of the liver metastasis and distal metastaisis outside the para-aortic region, as confirmed by contrast enhanced CT. No peritoneal dissemination and negative cytology at laparoscopic examination. 4) Macroscopic 0,1,2,3,5 (excpet for type 3 which is more than 8cm in diameter) 5) Primary tumor with >=3 cm esophageal invasion by clinical imagings 6) Age between 20 and 75 at registration 7) Performance Status(ECOG) 0 or 1 8) No prior chemotherapy or radiotherapy and no prior surgery for gastric carcinoma 9) No acute hemorrhage from primary tumor 10)Fair oral intake 11)blood test WBC >= 3,000/mm3 and <= 12,000/mm3 NEU >= 1,500/mm3 Hb >= 9.0 g/dl Platelet >= 100,000/mm3 GOT,GPT <= 100IU T.bil <= 2.0 mg/dl Creatinin <= 1.2mg/dl 24Ccr >= 60ml/min/body 12)Written informed consent
Key exclusion criteria	1) Patient with clinically obvious infecton 2) Serious complications(cardiac disease, respiratory dysfunction, bleeding disorder, severe HT or DM) 3) Gastric remnant cancer 4) Synchronous or metachronous malignancy in other organs including 5-year disease-free survival 5) Gastric cancer wtih distant metastasis 6) Past history of drug allergy of docetaxel or CDDP or S-1 7,8) Difficulty to join the trial due to psychosis or psychotic symptoms or central nervous system damage 9) Probable pregnancy, and the period of lactation 10)Not fit to the protocol treatment by the physicion's dicision
Target sample size	30

Research contact person
Name of lead principal investigator	Sachio Fushida, MD, PhD
Organization	Kanazawa University Hospital
Division name	Gastroenterlogic surgery
Address	13-1, Takara-machi, Kanazawa, Ishikawa 920-8641, Japan
TEL	076-265-2362
Email	fushida@staff.kanazawa-u.ac.jp

Public contact
Name of contact person	Jun Kinoshita, MD
Organization	Kanazawa University Hospital
Division name	Gastroenterlogic surgery
Address	13-1, Takara-machi, Kanazawa, Ishikawa 920-8641, Japan
TEL	076-265-2362
Homepage URL
Email	junkino0416@gmail.com

Sponsor
Institute	Digestive Disease Support Organization (DDSO)
Institute
Department

Funding Source
Organization	Digestive Disease Support Organization (DDSO)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	1)Department of surgery, Toyama prefectural central hospital 2)1st Department of Surgery Faculty of Medicine University of Fukui 3)Department of surgery, Saiseikai Yahata general hospital
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	2011 Year 08 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 06 Month 28 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date
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 07 Month 25 Day
Last modified on	2017 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007093