UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001025
Receipt number R000001236
Scientific Title Phase I study of preoperative Docetaxel, Cisplatin and S-1 for patients with advanced gastric cancer
Date of disclosure of the study information 2008/02/15
Last modified on 2009/06/16 14:47:50

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Basic information

Public title

Phase I study of preoperative Docetaxel, Cisplatin and S-1 for patients with advanced gastric cancer

Acronym

Phase I study of preoperative DCS therapy for advanced gastric cancer

Scientific Title

Phase I study of preoperative Docetaxel, Cisplatin and S-1 for patients with advanced gastric cancer

Scientific Title:Acronym

Phase I study of preoperative DCS therapy for advanced gastric cancer

Region

Japan


Condition

Condition

Patients with unresectable gastric cancer due to limited invasion and/or metastasis.

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Determine the maximum tolerable dose (MTD) and recommended dose (RD) as a preoperative chemotherapy which are achievable the safety surgical resection.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

Safety

Key secondary outcomes

Adverse events
Ratio of complete treatment
Response rate of preoperative chemotherapy


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

Docetaxel day 1, 15
Cisplatin dat 1, 15
S-1 80mg/m2 day 1-14
every 28 days for 2 cycles followed by gastrectomy

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 confirmed as gastric cancer
2. patients with unresectable advanced gastric cancer due to limited invasion and/or metastasis.
3. Age 20-75
4. PS 0-1
5. No prior therapy including chemotherapy, radiation and surgery.
6. Patients who can take medication orally.
7. Sufficient function of important organs.
8. Life expectancy > 8weeks
9. Written informed consent

Key exclusion criteria

1. Active infection
2. Other severe complications
3. Active double cancer
4. CNS metastasis
5. Pericardiac fluid
6. Mortor paralysis or peripheral neural disturbance.
7. History of severe allergy against drug.
8. Severe peritoneal metastasis
9. Pregnant women or women who like to be pregnant.
10. Doctor' s dicision not to be registered to this study.

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Fujimura

Organization

Kanazawa University Hospital

Division name

Gastroenterologic Surgery

Zip code


Address

Takara-machi 13-1, Kanazawa

TEL

076-265-2362

Email



Public contact

Name of contact person

1st name
Middle name
Last name Sachio Fushida

Organization

Kanazawa University Hospital

Division name

Gastroenterologic Surgery

Zip code


Address

Takara-machi 13-1, Kanazawa

TEL

076-265-2362

Homepage URL


Email



Sponsor or person

Institute

Dept. of Gastroenterologic Surgery,
Kanazawa University Hospital

Institute

Department

Personal name



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

2008 Year 02 Month 15 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2007 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2007 Year 10 Month 01 Day

Last follow-up date

2009 Year 06 Month 01 Day

Date of closure to data entry

2009 Year 06 Month 01 Day

Date trial data considered complete

2009 Year 06 Month 01 Day

Date analysis concluded

2009 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 02 Month 12 Day

Last modified on

2009 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001236


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name