UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of neoadjuvant chemotherapy of TS-1, CDDP and Paclitaxel for resectable large type 3 or type 4 gastric cancer
Acronym	Phase II study of neoadjuvant chemotherapy of TS-1, CDDP and Paclitaxel for advanced gastric cancer
Scientific Title	Phase II study of neoadjuvant chemotherapy of TS-1, CDDP and Paclitaxel for resectable large type 3 or type 4 gastric cancer
Scientific Title:Acronym	Phase II study of neoadjuvant chemotherapy of TS-1, CDDP and Paclitaxel for advanced gastric cancer
Region	Japan

Condition
Condition	Advanced gastric cancer
Classification by specialty	Hematology and clinical oncology Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to evaluate the efficacy and safety of neoadjuvant chemotherapy of TS-1, CDDP and Paclitaxel for highly advanced gastric cancer (resectable large type 3 or type 4).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	2-year overall survival
Key secondary outcomes

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 Maneuver
Interventions/Control_1	Neoadjuvant chemotherapy TS-1: 80mg/m2 Day 1-14 CDDP: 20mg/m2 Day 1, 15 Paclitaxel: 100mg/m2 Day 1, 15 Surgery should be performed after 2 courses of neoadjuvant chemotherapy.
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) adenocarcinoma of the stomach 2) Macroscopically either large Type 3 (more than 8cm)or 4 3) Without neither liver nor pritoneal metastasis 4) The invasion to esophagus is within 3cm. 5) Age: From 20y.o to 75 y.o. 6) ECOG PS 0 or 1 7) No prior treatment 8) Possible oral intake 9) Sufficient function of important organs 10) written informed consent
Key exclusion criteria	1) with severe drug allergy 2) with highly lymph node metastases 3) with severe infection 4) with severe diarrhea 5) with severeintestinal paralysis or ileus 6) with interstitial pneumonia or pulmonary fibrosis with other active malignant disease 7) with active other malignancy 8) with severe diabetes 9 ) with severe heart disease 10) pregnant or nursing women or women who like be pregnant and willing to get pregnant
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kitagawa Yuko
Organization	School of Medicine, Keio University
Division name	Department of Surgery
Zip code
Address	35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL	03-3353-1211
Email	kitagawa@a3.keio.jp

Public contact
Name of contact person	1st name Middle name Last name Tsunehiro Takahashi
Organization	School of Medicine, Keio University
Division name	Department of Surgery
Zip code
Address	35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	tsunehiro-t@a8.keio.jp

Sponsor
Institute	School of Medicine, Keio University
Institute
Department

Funding Source
Organization	School of Medicine, Keio University
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	2014 Year 06 Month 20 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	Terminated
Date of protocol fixation	2013 Year 02 Month 12 Day
Date of IRB	2013 Year 04 Month 22 Day
Anticipated trial start date	2013 Year 04 Month 22 Day
Last follow-up date	2015 Year 12 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 06 Month 20 Day
Last modified on	2019 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016684