UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021376 |
|---|---|
| Receipt number | R000024650 |
| Scientific Title | A phase I trial of intraperitoneal docetaxel and cisplatin with S-1 for treatment of gastric cancer with peritoneal dissemination |
| Date of disclosure of the study information | 2016/03/07 |
| Last modified on | 2016/03/07 16:40:22 |
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Basic information
Public title
A phase I trial of intraperitoneal docetaxel and cisplatin with S-1 for treatment of gastric cancer with peritoneal dissemination
Acronym
A phase I trial of intraperitoneal docetaxel and cisplatin with S-1
Scientific Title
A phase I trial of intraperitoneal docetaxel and cisplatin with S-1 for treatment of gastric cancer with peritoneal dissemination
Scientific Title:Acronym
A phase I trial of intraperitoneal docetaxel and cisplatin with S-1
Region
| Japan |
Condition
Condition
gastric cancer with periotoneal metastasis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of intraperitoneal docetaxel and cisplatin with S-1 for gastric cancer with peritoneal metastasis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recommended dose (RD)
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
CDDP is administered intraperitoneally with an initial dose of 25 mg/m2 (level 1), stepped up to 45 mg/m2 at day1,15 depending on observed toxicity. DOC is administered intraperitoneally at a dose of 45 mg/m2 at day1,15. S-1 is administered from day1 to day15 in 4-week 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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. presence of gastric adenocarcinoam confirmed by histopathology
2. presence of peritoneal metastasis confirmed by staging laparoscopy or MDCT
3. presence of mesurable or evaluable lesion
4. no prior treatment of chemotherapy or radiation therapy against any other malignancies
5. aged 20 to75 year old
6. performance status of 0 or 2 on Eastern Cooperative Oncology Group (ECOG) scale
7.with adequate oran function
8.sufficient oral intake
9.expected survival period over 3 months.
10.written informed consent
11.with a good condition of important organs recent 14 days
a)WBC>=3,000/mm3
b)neutrophil>=1,500/mm3
c)platelet>=100,000/mm3
d)hemoglobin>=9.0g/dl
e)total bilirubin<=2.0mg/dl
f)AST(GOT)<=150IU/L
g)ALT(GPT)<=150IU/L
h)serum creatinine<=1.2mg/dl
i)creatinin clearance>=50ml/min
Key exclusion criteria
1.with history of allergy against S-1,docetaxel,or cisplatin
2.with following severe diseases
a)uncontrolled DM
b)ischemic heart disease/arrythmia requiring treatment
c)liver cirrhosis and/or liver failure
d)heart failure, cardic infarction during recent 6 months
e) known bleeding disorders
3.active infection diseases with fever
4.pleural or cardiac effusion requiring treatment
5.symptomatic brain metastasis
6.with active double cancer
7.interstitial pneumonitis, pulmonary fibrosis
8.neurological disorder
9.no current pregnancy or lactation
10.with massive ascites
11.patients whom doctor decide not ro register to this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachio Fushida |
Organization
Kanazawa University
Division name
Department of Gastroenterologic Surgery
Zip code
Address
13-1 Takaramachi, Kanazawa, 920-8641, Japan
TEL
+81-76-265-2362
fushida@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Kinoshita |
Organization
Kanazawa University
Division name
Department of Gastroenterologic Surgery
Zip code
Address
13-1 Takaramachi, Kanazawa, 920-8641, Japan
TEL
+81-76-265-2362
Homepage URL
junkino0416@gmail.com
Sponsor or person
Institute
Department of Gastroenterologic Surgery, Kanazawa Universiy
Institute
Department
Personal name
Funding Source
Organization
DDSO (Digestive Disease Supporting Organization)
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
| 2016 | Year | 03 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | 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
| 2016 | Year | 03 | Month | 07 | Day |
Last modified on
| 2016 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024650
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