UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012247 |
|---|---|
| Receipt number | 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 11:54:45 |
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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
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
kobadai@med.nagoya-u.ac.jp
Sponsor or person
Institute
Chubu Clinical Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014317
