UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006674
Receipt number R000007825
Scientific Title A Phase II study of neoadjuvant combination chemotherapy with TS-1, cisplatin and Paclitaxel (PCS) for resectable advanced gastric cancer.
Date of disclosure of the study information 2011/11/08
Last modified on 2017/05/10 12:04:17

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Basic information

Public title

A Phase II study of neoadjuvant combination chemotherapy with TS-1, cisplatin and Paclitaxel (PCS) for resectable advanced gastric cancer.

Acronym

NECESSIT study

Scientific Title

A Phase II study of neoadjuvant combination chemotherapy with TS-1, cisplatin and Paclitaxel (PCS) for resectable advanced gastric cancer.

Scientific Title:Acronym

NECESSIT study

Region

Japan


Condition

Condition

resectable advanced gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and tolerability of combination chemotherapy with TS-1, Cisplatin and Paclitaxel in resectable advanced gastric cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

response rate

Key secondary outcomes

pathological complete response rate
recurrence-free survival time
progression-free survival
overall survival
proportion of transit surgery
proportion of R0 resection
Accomplishment rate
down stage rate
frequency and grade of adverse postoperative complication
frequency and grade of adverse event


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

TS-1 administered for 14 days followed by 7 days rest according to body surface area.
Cisplatin is administered intravenously in dosage of level at day 1 and day 8.
Paclitaxel is administered intravenously in dosage of level at day 1 and day 8.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histopathological confirmation of Adenocarcinoma
2) resectable advanced gastric cancer
3) measurable disease
4) Age over 20
5) ECOG performance status of 0 to 2
6) Sufficient function of important organs
Leu : &#8805; 500 /mm3 and&#8804;12,000 /mm3
Neu : &#8805; 2,000 /mm3
Plate : &#8805; 100,000 /mm3
hemoglobin : &#8805; 9.0 g/dL
AST, ALT : <100 IU/L
St.bil : < 1.5 mg/dL
Ccr : &#8805;60 ml/min
7) Ability to ingestion intake and drug administration orally.
8) Informed consent is obtained.

Key exclusion criteria

1) With severe allergy to TS-1, Cisplatin and Paclitaxel
2) Women who are pregnant or breastfeeding.
3) Men who are unwilling to avoid pregnancy.
4) Active infection and inflammation.
5) History of cardiac disease
6) Dyspnea at rest

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Motohiro Imano

Organization

Kinki University Faculty of Medicine

Division name

Department of Surgery

Zip code


Address

377-2 Ohnohigashi, Osakasayama Osaka

TEL

072-366-0221

Email

imano@med.kindai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Motohiro Imano

Organization

Kinki University Faculty of Medicine

Division name

Department of Surgery

Zip code


Address

377-2 Ohnohigashi, Osakasayama Osaka

TEL

072-366-022

Homepage URL


Email

imano@med.kindai.ac.jp


Sponsor or person

Institute

Kinki University Faculty of Medicine

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

近畿大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2011 Year 11 Month 08 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

Main results already published

Date of protocol fixation

2011 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date

2022 Year 07 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 11 Month 05 Day

Last modified on

2017 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007825


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name