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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006036
Receipt No. R000007093
Scientific Title Phase II study of Docetaxel, Cisplatin and S1 followed by surgery in advanced gastric cancer with lymph node metastasis of the paraaorta
Date of disclosure of the study information 2011/08/01
Last modified on 2017/07/29

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Basic information
Public title Phase II study of Docetaxel, Cisplatin and S1 followed by surgery in advanced gastric cancer with lymph node metastasis of the paraaorta
Acronym Paraaorta GC preoperative DCS Phase II
Scientific Title Phase II study of Docetaxel, Cisplatin and S1 followed by surgery in advanced gastric cancer with lymph node metastasis of the paraaorta
Scientific Title:Acronym 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
1st name
Middle name
Last name Sachio Fushida, MD, PhD
Organization Kanazawa University Hospital
Division name Gastroenterlogic surgery
Zip code
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
1st name
Middle name
Last name Jun Kinoshita, MD
Organization Kanazawa University Hospital
Division name Gastroenterlogic surgery
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2011 Year 08 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
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 Open public recruiting
Date of protocol fixation
2011 Year 06 Month 28 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000007093

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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