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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015631
Receipt No. R000018147
Scientific Title A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)
Date of disclosure of the study information 2014/11/10
Last modified on 2018/10/07

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Basic information
Public title A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)
Acronym A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)
Scientific Title A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)
Scientific Title:Acronym A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)
Region
Japan

Condition
Condition large type 3 or type 4 gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy and safety of preoperative TS-1+CDDP+DTX therapy (DCS therapy) and followed curative surgical operation for large type 3 or type 4 gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes incidence of curative resection (R0 ratio)
Key secondary outcomes Preoperative treatment completion rate
Postoperative treatment completion rate
Disease Free Survival
Overall Survival (OS)
Response Rate of preoperative chemotherapy
(RECIST v 1.1)
Histological Response Rate of preoperative
Chemotherapy
AE rate of preoperative chemotherapy Incidence of postoperative adverse events

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 It takes four weeks for one course of DCS therapy (DTX 40 mg/m2 iv day 1, CDDP 60 mg/m2 iv day 1 and TS-1 80-120 mg/body day 1-14, followed by 2 weeks rest)
Standard treatment is two or three courses before surgical operation
Patients undergo surgical operation within 42 days of completion of 2-3 courses
After R0 surgical operation, one year TS-1 administration is followed.
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 by endoscopic detection
2)Macroscopic finding is type 4 or type 3 whose size is over 8 cm by endoscopy and/or CT within 28 days before registration
3)Without any P2, P3, liver metastases and/or paraaortic node metastases by CT, PET and/or laparoscopic detection within 28 days before registration
4)Without esophageal invasion longer than 3 cm by endoscopic detection within 28 days before registration
5)Age older than 20 years and younger than 75 years
6)Performance Status(ECOG): 0 or 1
7)Without any history of chemotherapy, radiation therapy and/or surgical operation for the gastric cancer
8)with good functions of important organs by a data taken within 2 weeks
of registration
a) WBC: =>4000/mm3 and <12,000 mm3
b) Neutrophil: =>1,500/mm3
c) Hemoglobin: =>8.0 g/dl
d) Platelet: =>100,000/mm3
e) AST: =< 100 IU/L
f) ALT: =< 100 IU/L
g) T.bil.: =<1.5 mg/dL
h) s-cleatinine: =<1.2mg/dL
i) creatinine clearance: =>60 ml/min/body
CC by Cockcroft-Gault method is available: => 60mL/min
9)enough oral intake
10)with written Informed Consent
Key exclusion criteria 1)with active double cancers excluding carcinoma in situ and/or prior
cancer cured with longer than 5 year interval period
2)with a history of severe allergic reaction against medicines
3)with active infectious diseases (over 38 centigrade of body temperature)
4)pregnant or nursing female
5)male expecting pregnancy of partner
6)with a history of cardiac infarction within 6 months
7)under continuous steroids medication
8)under continuous medication of phenytoin or warfarin
9)with uncontrollable diarrhea (frequent movement and/or watery stool)
10)with HBs antigen positive or HCV antibody positive
11)With severe diseases (collagen disease, intestinal paralysis, interstitial pneumonitis, and/or ischemic cardiac disease)
12)Any other patients whom the physician in charge of the study judges to
be unsuitable
Target sample size 45

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazumasa Fujitani
Organization Osaka General Medical Center
Division name Department of Surgery
Zip code
Address 3-1-56, Bandaihigashi, Sumiyosi-ku, Osaka-City, 558-8558, Japan
TEL 06-6692-1201
Email fujitani@gh.opho.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Jyunji Kawada
Organization Kaizuka City Hospital
Division name Department of Surgery
Zip code
Address 3-10-20, Hori, Kaizuka-City, Osaka Prefecture, 597-0015, Japan
TEL 072-422-5865
Homepage URL
Email j-kawada@umin.ac.jp

Sponsor
Institute Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Osaka Clinical Study Supporting Organization
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 (OGSG 参加施設)
大阪医科大学(大阪府)、大阪労災病院(大阪府)、市立貝塚病院(大阪府)、大阪急性期・総合医療センター(大阪府)、市立池田病院(大阪府)、箕面市立病院(大阪府)、市立豊中病院(大阪府)、北野病院(大阪府)、関西労災病院(兵庫県)、関西電力病院(大阪府)、八尾市立病院(大阪府)、市立東大阪医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 10 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 No longer recruiting
Date of protocol fixation
2014 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 16 Day
Last follow-up date
2021 Year 06 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 11 Month 07 Day
Last modified on
2018 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018147

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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