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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012785
Receipt No. R000014936
Scientific Title Feasibility study of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for stage III gastric cancer
Date of disclosure of the study information 2014/01/08
Last modified on 2014/01/08

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Basic information
Public title Feasibility study of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for stage III gastric cancer
Acronym Feasibility study of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for stage III gastric cancer
Scientific Title Feasibility study of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for stage III gastric cancer
Scientific Title:Acronym Feasibility study of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for stage III gastric cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the completion rate , efficacy and safety of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for StageIII gastric cancer
Basic objectives2 Others
Basic objectives -Others completion rate
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Treatment completion rate after 2 cycle of S-1, DTX plus CDDP
Key secondary outcomes Overall Survival, Relapse Free Survival, Completion rate of S-1 for 1year, Safety

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
Interventions/Control_1 1st course (S-1 alone): S-1 80mg/m2 d1-14, q3w
Treatment consisted of 2nd and 3rd courses of S-1 (80 mg/m2/day, b.i.d.) for 14 days followed by a 7-day rest. Docetaxel (35 mg/m2 iv) and Cisplatin (35 mg/m2 iv) on day 1 and 15, q4w.

After 3rd course, S-1 alone e is given until 1 year post 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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Histopathologically proven gastric cancer
(2) D2 lymph-node dissection woti R0 surgery
(3) Patients with StageIIIA, StageIIIB or StageIIIC gastric cancer
(4) No previous treatment (chemotherapy, radootherapy) for any cancer
(5) ECOG performance status 0 or 1.
(6) 20 years of age and older
(7) Patients who can take medecine orally
(8) Without any other severe diseases
WBC: 3,500 - 12,000 /mm3
ANC: > 2,000 /mm3
Hgb: > 9.0 g/dL
Platelets: > 100,000 /mm3
total bilirubin: < 1.5xULN
Total bilirubin: < 1.5xULN
AST and ALT: < 2.5xULN
Creatinine: < 1.2 mg/dL
(9)Written informed consent
Key exclusion criteria (1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma, and multicentric cancer.
(2) Patients who are contraindicated to S-1, CDDP, and DTX.
(3) Patient is taking flucytosine and phenytoin.
(4) Patients with the history of severe drug hypersensitivity.
(5) Patients with severe complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis, pulmonary fibrosis, severe diabetes, heart failure, renal failure, liver cirrhosis, liver failure, etc.).
(6) Patients with diarrheal disease or watery diarrhea.
(7) Pregnant and/or nursing women
(8) Patients with positive HBs antigen
(9) Any subject judged by the investigator to be unfit for any reason to participate in the study.

Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Hirahara, M.D., Ph.D.
Organization Shimane University Hospital
Division name Digestive and General Surgery
Zip code
Address 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan
TEL 0853-20-2232
Email norinori@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Hirahara, M.D., Ph.D.
Organization Shimane University Hospital
Division name Digestive and General Surgery
Zip code
Address 89-1, Enya-cho, Izumo, Shimane, 693-8501, Japan
TEL 0853-20-2232
Homepage URL
Email norinori@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Hospital
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)

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
2014 Year 01 Month 08 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
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 24 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
2014 Year 01 Month 08 Day
Last modified on
2014 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014936

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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