UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012151 |
|---|---|
| Receipt number | R000014184 |
| Scientific Title | Phase 1 and 2 study on Negative-balance isolated pelvic perfusion |
| Date of disclosure of the study information | 2013/10/29 |
| Last modified on | 2016/05/06 11:23:37 |
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Basic information
Public title
Phase 1 and 2 study on Negative-balance isolated pelvic perfusion
Acronym
Phase 1 and 2 study on NIPP
Scientific Title
Phase 1 and 2 study on Negative-balance isolated pelvic perfusion
Scientific Title:Acronym
Phase 1 and 2 study on NIPP
Region
| Japan | North America | Europe |
Condition
Condition
Advanced bladder cancer
Advanced uterine cancer
Recurrent rectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Obstetrics and Gynecology |
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of Negative-balanced isolated pelvic perfusion for advanced bladder and uterine cancer, and recurrent rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year survival rate
Progression free survival
Antitumor effect (RECIST)
Adverse events (CTCAE grade) within 4 weeks after treatment
Key secondary outcomes
Performance status
Visual analog scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Establish isolated pelvic perfusion using balloon catheters. Perform the procedure more than twice, more than 2 weeks apart.
Initial dose is cisplatin 190mg/m2 plus 5-FU 2000mg/m2 for bladder cancer, cisplatin 190mg/m2 plus 5-FU 2000mg/m2 for uterine cervical cancer and rectal cancer, and cisplatin 190mg/m2 plus 5-FU 2000mg/m2 for uterine body cancer.
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
| Not applicable |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Written informed consent
2. No indication of surgical resection
3. Apparent increase in tumor size after performing chemotherapy and radiation therapy according to a standard protocol
4. Performance status of 0-2 according to the Eastern Cooperative Oncology Group (ECOG) score
5. Acceptable renal function (serum creatinine less than 1.2 mg/dl)
6. Acceptable bone marrow function (leukocyte count 3500/mm3 or more, and platelet count 50000/mm3 or more).
Key exclusion criteria
1. Contraindication to angiography (due to severe side effect of contrast media)
2. High risk for general anesthesia
3. Severe comorbidities
4. Vascular anatomy not suitable for catheterization
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Murata |
Organization
Nippon medical school
Division name
Department of Radiology
Zip code
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL
03-3822-2131
genji@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Murata |
Organization
Nippon medical school
Division name
Department of Radiology
Zip code
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
genji@nms.ac.jp
Sponsor or person
Institute
Nippon medical school
Institute
Department
Personal name
Funding Source
Organization
Nippon medical school
Organization
Division
Category of Funding Organization
Self funding
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 | 10 | Month | 29 | 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
Date of protocol fixation
| 2013 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 29 | 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 | 10 | Month | 28 | Day |
Last modified on
| 2016 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014184
