UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015631
Receipt number 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 2021/11/27 18:09:48

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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

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

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 or person

Institute

Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)

Institute

Department

Personal name



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

48

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

Completed

Date of protocol fixation

2014 Year 10 Month 04 Day

Date of IRB

2014 Year 11 Month 26 Day

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

2021 Year 09 Month 27 Day


Other

Other related information

Registered with JRCT on 26/03/2019
Certification number: CRB5200005
Trial ID: jRCTs051180195


Management information

Registered date

2014 Year 11 Month 07 Day

Last modified on

2021 Year 11 Month 27 Day



Link to view the page

Value
https://center6.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