UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019206 |
|---|---|
| Receipt number | R000022204 |
| Scientific Title | Exploratory study of intraperitoneal paclitaxel combined with mFOLFOX6 for gastric cancer patients with peritoneal metastasis and inadequate oral intake |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2019/04/05 09:39:17 |
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Basic information
Public title
Exploratory study of intraperitoneal paclitaxel combined with mFOLFOX6 for gastric cancer patients with peritoneal metastasis and inadequate oral intake
Acronym
Phase I/II study of FOLFOX+IP PTX
Scientific Title
Exploratory study of intraperitoneal paclitaxel combined with mFOLFOX6 for gastric cancer patients with peritoneal metastasis and inadequate oral intake
Scientific Title:Acronym
Phase I/II study of FOLFOX+IP PTX
Region
| Japan |
Condition
Condition
gastric cancer with peritoneal metastasis
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of intraperitoneal paclitaxel combined with mFOLFOX6 in gastric cancer patients with peritoneal metastasis and inadequate oral intake
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
1-year overall survival
Key secondary outcomes
progression-free survival
time to treatment failure
response rate
negative conversion rate on peritoneal cytology
safety
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
mFOLFOX6 on days 1 and 15
intraperitoneal paclitaxel on days 1, 8 and 15 in 28days
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) histologically or cytologically proven gastric adenocarcinoma
2) peritoneal metastasis confirmed by diagnostic imaging, staging laparoscopy or laparotomy
3) difficult to be treated with oral anticancer agents due to inadequate oral intake
4) no previous chemotherapy or previous chemotherapy less than one month without disease progression or severe adverse events
5) adequate organ functions(according to the laboratory data which was taken within 14 days before registration)
neutrophil count > 1,500/mm3
hemoglobin > 8.0 g/dl
platelet count > 100,000/mm3
serum transaminases < 100/UI
total serum bilirubin < 2.0mg/dl
creatinine clearance > 50mL/min
6) Eastern Cooperative Oncology Group performance status 0-2
7) HER2 negative or unknown
8) an expected survival period of more than 3 months.
9) age between 20 and 80 years
10) written informed consent
Key exclusion criteria
1) metastasis to distant organ sites other than the peritoneum, ovary or abdominal lymph nodes
2) other active concomitant malignancies
3) massive ascites which requires frequent drainage for palliation
other severe medical conditions
4) contraindication for fluorouracil, levofolinate, oxaliplatin or paclitaxel
5) past or current severe heart disease
6) severe complications such as interstitial pneumonitis, pulmonary fibrosis, uncontrollable diabetes mellitus, renal failure or liver cirrhosis
7) pregnant or nursing women
8) judged to be unfit to participate in this study by investigators
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironori Ishigami |
Organization
The University of Tokyo
Division name
Department of chemotherapy
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
ishigami-tky@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironori Ishigami |
Organization
The University of Tokyo
Division name
Department of chemotherapy
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
ishigami-tky@umin.net
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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 | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 02 | Day |
Last modified on
| 2019 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022204
