UMIN-CTR Clinical Trial

Public title

Phase II study of Docetaxel, Cisplatin and S1 followed by surgery in advanced gastric cancer with lymph node metastasis of the paraaorta

Acronym

Paraaorta GC preoperative DCS Phase II

Scientific Title

Phase II study of Docetaxel, Cisplatin and S1 followed by surgery in advanced gastric cancer with lymph node metastasis of the paraaorta

Scientific Title:Acronym

Paraaorta GC preoperative DCS Phase II

Region

Japan

Condition

gastric cancer with para-aortic lymph node metastasis

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to evaluate the safty and efficacy of Docetaxel+CDDP+S-1 as preoperative chemotherapy for gastric carcinoma in patients with para-aortic lymph node metastasis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

histological response of para-aortic lymph node in preoperative chemotherapy

Key secondary outcomes

proportion of completion of treatment, proportion of curative resection,
response rate(RECISTv.1.0),
3-year survival,
proportion of toxicities,
proportion of treatment related death

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

Maneuver

Interventions/Control_1

Preoperative chemotherapy with Docetalxel+CDDP+S-1 followed by gastrectomy with D2 and para-aortic nodal dissection

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) Histologically proven gastric carcinoma
2) Para-aortic lymph node metastassis
which was more than 10mm in diameter by
contrast enhanced CT
3) None of the liver metastasis and distal
metastaisis outside the para-aortic
region, as confirmed by contrast
enhanced CT. No peritoneal
dissemination and negative cytology at
laparoscopic examination.
4) Macroscopic 0,1,2,3,5 (excpet for type
3 which is more than 8cm in diameter)
5) Primary tumor with >=3 cm esophageal
invasion by clinical imagings
6) Age between 20 and 75 at registration
7) Performance Status(ECOG) 0 or 1
8) No prior chemotherapy or radiotherapy
and no prior surgery for gastric
carcinoma
9) No acute hemorrhage from primary tumor
10)Fair oral intake
11)blood test
WBC >= 3,000/mm3 and <= 12,000/mm3
NEU >= 1,500/mm3
Hb >= 9.0 g/dl
Platelet >= 100,000/mm3
GOT,GPT <= 100IU
T.bil <= 2.0 mg/dl
Creatinin <= 1.2mg/dl
24Ccr >= 60ml/min/body
12)Written informed consent

Key exclusion criteria

1) Patient with clinically obvious
infecton
2) Serious complications(cardiac disease,
respiratory dysfunction, bleeding
disorder, severe HT or DM)
3) Gastric remnant cancer
4) Synchronous or metachronous malignancy
in other organs including 5-year
disease-free survival
5) Gastric cancer wtih distant metastasis
6) Past history of drug allergy of
docetaxel or CDDP or S-1
7,8) Difficulty to join the trial due to
psychosis or psychotic symptoms or
central nervous system damage
9) Probable pregnancy, and the period of
lactation
10)Not fit to the protocol treatment by
the physicion's dicision

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Sachio Fushida, MD, PhD

Organization

Kanazawa University Hospital

Division name

Gastroenterlogic surgery

Zip code

Address

13-1, Takara-machi, Kanazawa, Ishikawa 920-8641, Japan

TEL

076-265-2362

Email

fushida@staff.kanazawa-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Jun Kinoshita, MD

Organization

Kanazawa University Hospital

Division name

Gastroenterlogic surgery

Zip code

Address

13-1, Takara-machi, Kanazawa, Ishikawa 920-8641, Japan

TEL

076-265-2362

Homepage URL

Email

junkino0416@gmail.com

Institute

Digestive Disease Support Organization (DDSO)

Institute

Department

Personal name

Organization

Digestive Disease Support Organization (DDSO)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

1)Department of surgery, Toyama
prefectural central hospital
2)1st Department of Surgery Faculty of
Medicine University of Fukui
3)Department of surgery, Saiseikai Yahata
general hospital

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

2011

Year

08

Month

01

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

Open public recruiting

Date of protocol fixation

2011

Year

06

Month

28

Day

Date of IRB

Anticipated trial start date

2011

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

07

Month

25

Day

Last modified on

2017

Year

07

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007093