UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of TAS-102 in patients with advanced gastric cancer after progression on 1 or 2 prior systemic chemotherapy
Title of the study (Brief title)	TAS-102 Phase II GC
Region	Japan

Condition
Condition	advanced gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of TAS-102 in patients with advanced gastric cancer after progression on 1 or 2 prior systemic chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Disease control rate (DCR)
Key secondary outcomes	Response rate (RR) Progression free survival (PFS) Overall survival (OS) Adverse events PK parameter

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	TAS-102 (35 mg/m2/dose BID) is administered orally on Day1-5 and Day8-12 in 28-day cycles.
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) Histologically proven gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma. 2) Inoperable, recurrent or metastatic disease. 3) Tumor progression during prior chemotherapy or within 2 months after prior chemotherapy. 4) >= 20 years old. 5) ECOG performance status of <= 2. 6) Measurable disease without irradiation according to RECIST ver1.1. 7) Prior chemotherapies for advanced gastric cancer are as follows. (In case of progression during adjuvant/neoadjuvant therapy or <= 6 months after the last administration of adjuvant/neoadjuvant therapy, the adjuvant/neoadjuvant therapy will be considered one prior treatment.) i. Include chemotherapy with 5-FU. ii. Include chemotherapy with platinum derivative. iii. Include chemotherapy with taxane or irinotecan. iv. No. of prior chemotherapies <= 2. 8) Adequate organ function. 9) No blood transfusion within 14 days prior to enrollment. 10) AE related to prior chemotherapy, radiation therapy or surgery must be Grade <= 1 according to CTCAE. (except alopecia, peripheral sensory neuropathy, skin hyperpigmentation and dysgeusia) 11) Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment. 12) Adequate oral intake. 13) Written informed consent.
Key exclusion criteria	1) Administration of chemotherapy within 2 weeks prior to enrollment. 2) Major surgery or radiation therapy within 4 weeks prior to enrollment. Except bowel bypass surgery or enterostomy has passed over 2 weeks. 3) Investigational drugs were administrated within 4 weeks prior to enrollment. 4) Prior chemotherapy with TAS-102. 5) Known hypersensitivity to TAS-102 or excipients. 6) Patients with CNS metastases. 7) Malignant pleural effusion, ascites or cardiac effusion requiring invasive treatment. (such as ascites drainage) 8) Synchronous or asynchronous (within 3 years) other cancer except carcinoma in situ or intramucosal carcinoma. 9) Any severe and/or uncontrolled medical conditions. 10) Positive HBs antigen or HCV antibody. Known positive serology for HIV. 11) Chronic treatment with steroids or another immunosuppressive agent. 12) Not use adequate methods of contraception. (duplex barrier method or intrauterine device) 13) Patient is unwilling or unable to comply with the protocol. 14) Patient is judged by the investigator to be inappropriate for study participation for any reason.
Target sample size	28

Research contact person
Name of lead principal investigator	Toshihiko Doi
Organization	National Cancer Center Hospital East
Division name	Gastrointestinal Oncology Division
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Email	tdoi@east.ncc.go.jp

Public contact
Name of contact person	Hideaki, BANDO, M.D.
Organization	National Cancer Center Hospital East
Division name	Gastrointestinal Oncology Division
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Homepage URL
Email	hbando@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Health and Labor Sciences Research Grant
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Taiho Pharmaceutical Co., Ltd.
Name of secondary funｄer(s)

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	独立行政法人国立がん研究センター東病院（千葉県） 静岡県立静岡がんセンター（静岡県） 愛知県がんセンター中央病院（愛知県） 独立行政法人国立病院機構四国がんセンター（愛媛県） 埼玉県立がんセンター（埼玉県） 公益財団法人がん研究会有明病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 03 Month 02 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 12 Month 14 Day
Anticipated trial start date	2012 Year 03 Month 01 Day
Last follow-up date	2014 Year 03 Month 01 Day
Date of closure to data entry	2014 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 03 Month 01 Day
Last modified on	2017 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008700