UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000686
Receipt number R000000823
Scientific Title A phase II study of preoperative S-1 plus Paclitaxel combination therapy and postoperative Paclitaxel followed by S-1 therapy for type 4 gastric cancer (OGSG 0502)
Date of disclosure of the study information 2007/04/23
Last modified on 2021/11/15 22:56:59

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Basic information

Public title

A phase II study of preoperative S-1 plus Paclitaxel combination therapy and postoperative Paclitaxel followed by S-1 therapy for type 4 gastric cancer (OGSG 0502)

Acronym

OGSG 0502

Scientific Title

A phase II study of preoperative S-1 plus Paclitaxel combination therapy and postoperative Paclitaxel followed by S-1 therapy for type 4 gastric cancer (OGSG 0502)

Scientific Title:Acronym

OGSG 0502

Region

Japan


Condition

Condition

For patients with type 4 gastric cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

For patients with type 4 gastric cancer which is resectable, a preoperative S-1 plus Paclitaxel combination therapy and postoperative Paclitaxel followed by S-1 therapy is evaluated on its response or feasibility.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

"The ratio of the patients who completed the regimen
The ratio of administered dose to the planed dose."

Key secondary outcomes

Response Rate
Overall Survival
Disease Free Survival
Histological CR


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

Treatment Methods
A three course S-1 plus Paclitaxel (S-1[80mg/day] between day 1 and 14, and Paclitaxel [50mg/m2] on day 1 and 8, followed by 7 days rest) is administered before surgery.. Surgical operation is performed 21-35 days after chemotherapy.
Fourteen to fifty-six days after surgical operation, a three course of Paclitaxel ( 50mg/m2 on day 1 and 8, followed by 14 days rest) is administered followed by a eight course of S-1 (80mg/day between day 1 and 14 followed by 7 days rest).

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 cancer
2.type 4 gastric cancer
3.N0-2 (not bulky)
4.curative resection A or B in the preoperative diagnosis,
5.Thracotomy is not necessary
6.PS 0-1 in ECOG
7.Age: 20-75 yo
8.No history of prior surgery or chemotherapy for cancer
9.No obvious bleeding from lesion or no obstruction of intestine
10.sufficient oral intake
11.No organ failure detected by blood examination
12.CCr is over 50ml/min in Cockcroft-Gault method
13.No severe complications or no active double cancer except resected cancer in situ
14.written informed consent

Key exclusion criteria

1.patients with severe diseases (non-treated ischemic cardiac disease, arrhythmia, liver cirrhosis, nterstitial pneumonia, fresh bleeding which needs transfusion, mental disorder, uncontrolled DM, intestinal obstruction, etc.)
2.febrile infection
3.allergy against polyoxyethylene-castor oil
4.under pregnancy or nursing
5.receiving steroids
6.receiving flucytosine, phenytoin or warfarin
7.doctors' decision

Target sample size

31


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fujitani Kazumasa

Organization

National Hospital Orgamnzation
Osaka Medical Center

Division name

Dpt.Surgery

Zip code


Address

2-1-14 2-1-14.Houenzaka, chuo-ku, Osaka, 540-0006

TEL

06-6942-1331

Email



Public contact

Name of contact person

1st name
Middle name
Last name Furukawa Hiroshi

Organization

Sakai City Hospital

Division name

Director

Zip code


Address

1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064

TEL

072-221-1700

Homepage URL


Email



Sponsor or person

Institute

OGSG

Institute

Department

Personal name



Funding Source

Organization

NPO Osaka Chinical 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



Other administrative information

Date of disclosure of the study information

2007 Year 04 Month 23 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

Terminated

Date of protocol fixation

2005 Year 03 Month 14 Day

Date of IRB


Anticipated trial start date

2005 Year 04 Month 01 Day

Last follow-up date

2009 Year 03 Month 01 Day

Date of closure to data entry

2009 Year 03 Month 01 Day

Date trial data considered complete

2009 Year 03 Month 01 Day

Date analysis concluded

2009 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2007 Year 04 Month 19 Day

Last modified on

2021 Year 11 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000823


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name