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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012247
Receipt No. R000014317
Scientific Title 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
Date of disclosure of the study information 2013/12/01
Last modified on 2017/04/10

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Basic information
Public title 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
Acronym Phase II study of nab-paclitaxel as second-line chemotherapy for metastatic or recurrent gastric cancer considering dose reduction on early points (CCOG1303)
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuhiro Kodera
Organization Nagoya University, Graduate School of Medicine
Division name Gastroenterorogical Surgery
Zip code
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
1st name
Middle name
Last name Daisuke Kobayashi
Organization Nagoya University, Graduate School of Medicine
Division name Gastroenterorogical Surgery
Zip code
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)

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
2013 Year 12 Month 01 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 No longer recruiting
Date of protocol fixation
2013 Year 10 Month 31 Day
Date of IRB
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

Other
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

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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