UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of nab-paclitaxel as second-line chemotherapy prior fluoropyrimidine resistance for metastatic or recurrent gastric cancer considering dose reduction on early points
Title of the study (Brief title)	Phase II study of nab-paclitaxel as second-line chemotherapy for metastatic or recurrent gastric cancer considering dose reduction on early points (CCOG1303)
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of nab-paclitaxel as second-line chemotherapy prior fluoropyrimidine resistance for metastatic or recurrent gastric cancer considering dose reduction on early points. To evaluate the correaltion between the expression of SPARC and the efficacy of nab-paclitaxel.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	disease free 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
Interventions/Control_1	nab-paclitaxel
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 or cytologically proven gastric adenocarcinoma (2) Presence of resected primary tumor to evaluate the expression of SPARC (3) Prior chemotherapy consisted of fluoropyrimidine for unresectable or recurrent gastric cancer (4) No past history of treatment related paclitaxel (5) Age : 20 years old and more (6) Performance status (ECOG) 0-2 (7) Life expectancy : 12 weeks and more (8) Adequate organ functions (9) Ability to understand and willingness to sign a written informed consent before study entry
Key exclusion criteria	(1) Past history of severe hypersensitivity to drug (2) Severe infectious disease that requires systemic treatment (3) Second primary malignancy except in situ carcinoma or prior malignancy treated within 5 years (4) Serious illness (5) Congestive heart failure, unstable angina or myocardial infarction (6) Much amount of pleural effusion, ascites or cardiac effusion (7) Peripheral nerve disorder (8) Presence of symptomatic or progressing CNS metastasis (9) Psychological illness (10) Pregnant or lactating woman. Women of child bearing potential not using a contraceptive method. Sexually active fertile men not using effective birth control. (11) Any patients judged by the investigator to be unfit to participate in the study
Target sample size	50

Research contact person
Name of lead principal investigator	Yasuhiro Kodera
Organization	Nagoya University, Graduate School of Medicine
Division name	Gastroenterorogical Surgery
Address	65 Tsurumai-cho Showa-ku Nagoya city
TEL	052-744-2253
Email	ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person	Daisuke Kobayashi
Organization	Nagoya University, Graduate School of Medicine
Division name	Gastroenterorogical Surgery
Address	65 Tsurumai-cho Showa-ku Nagoya city
TEL	052-744-2253
Homepage URL
Email	kobadai@med.nagoya-u.ac.jp

Sponsor
Institute	Chubu Clinical Oncology Group
Institute
Department

Funding Source
Organization	Chubu Clinical Oncology Group
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 10 Month 31 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2013 Year 11 Month 08 Day
Last modified on	2017 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014317