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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017652
Receipt No. R000020456
Scientific Title A phase II study of preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1 for the clinical Stage III gastric cancer
Date of disclosure of the study information 2015/05/22
Last modified on 2019/11/25

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Basic information
Public title A phase II study of preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1 for the clinical Stage III gastric cancer
Acronym A phase II study of preoperative DOS for cStage III gastric cancer
Scientific Title A phase II study of preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1 for the clinical Stage III gastric cancer
Scientific Title:Acronym A phase II study of preoperative DOS for cStage III gastric cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1 for the clinical Stage III gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3-year progression-free survival
Key secondary outcomes Overall survival, Progression-free survival, Response rate of preoperative chemotherapy, Pathological response rate, R0 resection rate, Proportion of adverse events.

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
Interventions/Control_1 preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1
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) Histological proven adenocarcinoma.
2) cStage III gastric or esophagogastric junction cancer.
3) Not Borrmann type 4 and not large (8cm or less) type 3.
4) Possible for R0 surgery.
5) No prior treatment of chemotherapy or radiation therapy and no history of surgery for gastric cancer.
6) No active gastrointestinal bleeding.
7) Possible oral intake or administration of adequate calories using an enteral feeding tube.
8) ECOG performance status of 0 or 1.
9) Aged 20 to 79 years old.
10) No prior treatment of chemotherapy, radiation or hormone therapy against any other malignancies.
11) No history of gastrectomy other than endoscopic mucosal resection.
12) Adequate organ function.
13) Written informed consent from patient.
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Past history of severe hypersensitivity to drugs.
3) Active infection.
4) Severe complications (interstitial pneumonia, pulmonary fibrosis, renal failure, liver failure, heart failure, uncontrollable diabetes millutus and Uncontrollable hypertension)
5) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason.
6) Edema of limbs and trunk by any reason.
7) Continuous systemic steroid therapy.
8) Under treatment with flucytosine, phenytoin, or warfarin.
9) Abnormal electrocardiogram or severe cardiovascular disease.
10) Severe diarrhea.
11) Positive HBs antigen.
12) Pregnant women, or women with the possibility of the pregnancy and men who want let to pregnancy.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yukinori
Middle name
Last name Kurokawa
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code 565-0871
Address 2-2-E2, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Email ykurokawa@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Yukinori
Middle name
Last name Kurokawa
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code 565-0871
Address 2-2-E2, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3251
Homepage URL
Email ykurokawa@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yakult Honsha
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 IRB, Osaka University Hospital
Address 2-2, Yamadaoka, Suita, Osaka, Japan
Tel 06-6210-8295
Email rinri@hp-crc.med.osaka-u.ac.jp

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
2015 Year 05 Month 22 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 50
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
2015 Year 05 Month 18 Day
Date of IRB
2015 Year 05 Month 18 Day
Anticipated trial start date
2015 Year 05 Month 25 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 22 Day
Last modified on
2019 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020456

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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