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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000006674
Receipt No. 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

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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
Institute Kinki University Faculty of Medicine
Institute
Department

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
URL(English) https://upload.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


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