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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000012151
Receipt No. 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

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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 Obsterics 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
Email 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
Email genji@nms.ac.jp

Sponsor
Institute Nippon medical school
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014184

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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