UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000857
Receipt number R000001029
Scientific Title Docetaxel and S-1 as adjuvant chemotherapy for pathological stage II, IIIA, IIIB gastric cancer
Date of disclosure of the study information 2007/10/19
Last modified on 2010/11/19 08:33:48

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Basic information

Public title

Docetaxel and S-1 as adjuvant chemotherapy for pathological stage II, IIIA, IIIB gastric cancer

Acronym

Docetaxel and S-1 as adjuvant chemotherapy

Scientific Title

Docetaxel and S-1 as adjuvant chemotherapy for pathological stage II, IIIA, IIIB gastric cancer

Scientific Title:Acronym

Docetaxel and S-1 as adjuvant chemotherapy

Region

Japan


Condition

Condition

Pathological stage II, IIIa, or IIIb gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm the feasibility of Docetaxel + S-1 as adjuvant chemotherapy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Feasibility of Docetaxel+S-1 4 cycles

Key secondary outcomes

Feasibility of Docetaxel+S-1 4 cycles followed by S-1 alone for 1 year,
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

Docetaxel(40mg/m2, day1), S-1(80mg/m2, day1-14) combination therapy, every 3 weeks, 4 cycles followed by S-1(80mg/m2, day1-14) monotherapy every 3 weeks until 1 year from 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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. Histologically confirmed Gastric cancer
2. Curatively resected gastric cancer(R0 surgery) with D2 lymph-node resection
3. Pathlogical Stage II, IIIA, IIIB
4. No prior chemotherapy for current disease.
5. Sufficient organ function (within 2 weeks before enrollment)
6. ECOG performance status 0-1.
7. Age &#8805;20 and <80 years old
8. Maximum of 8 weeks since surgery and patients who can take medicine orally.
9. Written informed consent.

Key exclusion criteria

1. A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.
2. Contraindication to S-1
3. Under treatment with flucytosine, phenytoin, or warfarin
4. Past history of severe drug hypersensitivity.
5. Uncontrolled medical conditions (e.g., Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray, malignant hypertension, congestive heart failure, myocardial infarction in previous 6 months, arrhythmia requiring treatment, hemorrhage, diabetes).
6. Hepatitis B/C
7. Diarrhea
8. Pregnant or lactating women and women of child bearing potential not using contraception
9. Severe peripheral edema.
10. Grade 2 or greater peripheral neuropathy.
11. HIV positive.
12. Patients judged by the investigator as unfit to be enrolled in the study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihiko Maehara

Organization

Kyushu University
Graduate school of medical sciences

Division name

Dept. of Surgery and Science

Zip code


Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan 812-8582

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiro Kakeji

Organization

Kyushu University

Division name

Dept. of Surgery and Science

Zip code


Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan 812-8582

TEL


Homepage URL


Email



Sponsor or person

Institute

Dept. of Surgery and Science, Kyushu University

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

2007 Year 10 Month 19 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 04 Month 06 Day

Date of IRB


Anticipated trial start date

2007 Year 06 Month 01 Day

Last follow-up date

2009 Year 07 Month 01 Day

Date of closure to data entry

2009 Year 08 Month 01 Day

Date trial data considered complete

2009 Year 09 Month 01 Day

Date analysis concluded

2009 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2007 Year 10 Month 18 Day

Last modified on

2010 Year 11 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001029


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name