UMIN-CTR Clinical Trial

Public title

A phase II study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for advanced gastric cancer.

Acronym

A phase II study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for advanced gastric cancer.

Scientific Title

A phase II study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for advanced gastric cancer.

Scientific Title:Acronym

A phase II study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for advanced gastric cancer.

Region

Japan

Condition

advanced gastric cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To examine the efficacy and safety of NAC combined with Docetaxel, cisplatin and TS-1 in advanced gastric cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Complete resection rate

Key secondary outcomes

Response rate
Pathological response
PFS, MST, 1-year survival, 3-year survival
Toxicity

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Docetaxel 60 mg/m2 1-hour IV day 8
Cisplatin 60 mg/m2 1-hour IV day 8
S-1 80 mg/m2 PO BID days 1-14

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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Written informed consent
2. Histologically or cytologically confirmed adenocarcinoma of the stomach
3. T2N1-3M0 in type IV or T3-4 N0-3 M0 in any types
4. Curative resection possible by image diagnosis
5. Measurable lesions according to RECIST guidelines.
6. No prior therapy including surgery, radiotherapy or chemotherapy for current disease.
7. No obvious hemorrhage or obstruction
8. Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
Hb _ 9.0 g/dL
WBC 4.0_1.2 x 109/L, ANC _ 2.0 x 109/L
Platelets _ 100 x 109/L
AST (SGOT) and ALT (SGPT) _ 100 U/I
Total bilirubin _ 1.5mg/dL
Serum creatinine _ UNL
Creatinine clearance _ 60mL/min
9. ECOG performance status 0-1
10. Life expectancy over 3 months
11. Age _20 and <75 years old
12. Patients who can take medicine orally

Key exclusion criteria

1. A history of hypersensitivity reaction to drugs formulated with polysorbate 80.
2. Patients contraindicated to docetaxel, cisplatin, S-1, or G-CSF.
3. Documented or suspected infection.
4. Uncontrolled medical conditions (e.g., malignant hypertension, congestive heart failure, myocardial infarction in previous 3 months, arrhythmia requiring treatment, diabetes, interstitial pneumonia, pulmonary fibrosis).
5. Grade 2 or greater peripheral neuropathy.
6. Patients with brain metastasis
7. Patients with diarrhea.
8. Active concomitant malignancy.
9. Pregnant or lactating women and women of child bearing potential not using contraception.
10. Men with partner willing to get pregnant
11. Patients judged by the investigator as unfit to be enrolled in the study.
12. Patients already enrolled in this study.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Tetsuji Takayama

Organization

Sapporo Medical University
School of Medicine

Division name

Dept. of Internal Medicine(4)

Zip code

Address

S1W17, Chuo-ku, Sapporo, 060-8556, Japan

TEL

011-611-2111

Email

Name of contact person

1st name
Middle name
Last name	Tetsuji Takayama, Yasushi Sato

Organization

Sapporo Medical University

Division name

Dept. of Internal Medicine(4)

Zip code

Address

S1W17, Chuo-ku, Sapporo, 060-8556, Japan

TEL

011-611-2111

Homepage URL

Email

Institute

Dept. of Internal Medicine(4)

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2007

Year

08

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Date of protocol fixation

2006

Year

04

Month

27

Day

Date of IRB

Anticipated trial start date

2007

Year

01

Month

01

Day

Last follow-up date

2011

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2007

Year

08

Month

15

Day

Last modified on

2010

Year

03

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000957