UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008632 |
|---|---|
| Receipt number | R000010143 |
| Scientific Title | Phase II study of a Combination of Paclitaxel and 5'-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric Cancer |
| Date of disclosure of the study information | 2012/08/06 |
| Last modified on | 2013/09/09 12:54:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II study of a Combination of Paclitaxel and 5'-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric Cancer
Acronym
Phase II study of a Combination of Paclitaxel and 5'-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric Cancer
Scientific Title
Phase II study of a Combination of Paclitaxel and 5'-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric Cancer
Scientific Title:Acronym
Phase II study of a Combination of Paclitaxel and 5'-DFUR in Patients with S-1 Failure Unresectable or Recurrent Gastric Cancer
Region
| Japan |
Condition
Condition
Advanced or recurrent gastric cancer previously treated with S-1
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical usefulness of combination chemotherapy with weekly paclitaxel and 5'-DFUR in S-1 failure advanced or recurrent gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Overall survival(OS), Progression-free survival(PFS), Time to Treatment Failure(TTF), Adverse Effect, QOL
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
The treatment included PTX 70 mg/m2 i.v. on days 1, 8, and 15 every 4 weeks and 5'-DFUR 600 mg/body p.o. everyday
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 unresectable or recurrent gastric cancer showing resistance to S-1.
2) ECOG Performance status:0-2
3) Up to one prior chemotherapy
4) 4 weeks rest after prior chemotherapy
5) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors. (RECIST)
6) Adequate organ functions:
i) hemoglobin >=9.0g/dL,
ii) WBC >=4000/mm3,
iii) neutrophils >=2000/mm3,
iv) platelets >=100,000/mm3,
v) AST(GOT)/ALT(GPT) <=2.5 X UL,
vi) total bilirubin <=1.5mg/dL,
vii) creatinine <=1.5mg/dL,
7) Life expectancy of more than 3 months
8) Age greater than 20
9) Informed consent approved by IRB
Key exclusion criteria
1) Drug hypersensitivity.
2) Infection and inflammation.
3) Prior infusion of paclitaxel
4) Peripheral neuropathy
5) Active synchronous malignancy.
6) Brain metastasis.
7) Severe mental disorders.
8) Symptomatic pulmonary fibrosis or interstitial pneumonia.
9) Severe systemic edema.
10) A large amount of pleural effusion or peritoneal fluid.
11) Severe heart disease.
12) Myocardial infarction within six months.
13) DM with insulin injection.
14) Pregnant patient
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Oka |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Digestive Surgery and Surgical Oncology
Zip code
Address
1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
sigefumi@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigefumi Yoshino |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Digestive Surgery and Surgical Oncology
Zip code
Address
1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
Homepage URL
sigefumi@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
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
| 2012 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2007 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | 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
| 2012 | Year | 08 | Month | 06 | Day |
Last modified on
| 2013 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010143
