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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025351
Receipt No. R000028665
Scientific Title Phase 1 clinical trial on the safety and efficacy of the negative-balance isolated pelvic perfusion (NIPP) for pelvic malignancy (uterine cervical cancer)
Date of disclosure of the study information 2017/01/05
Last modified on 2016/12/21

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Basic information
Public title Phase 1 clinical trial on the safety and efficacy of the negative-balance isolated pelvic perfusion (NIPP) for pelvic malignancy (uterine cervical cancer)
Acronym NIPP phase 1
Scientific Title Phase 1 clinical trial on the safety and efficacy of the negative-balance isolated pelvic perfusion (NIPP) for pelvic malignancy (uterine cervical cancer)
Scientific Title:Acronym NIPP phase 1
Region
Japan

Condition
Condition Uterine cervical cancer
Classification by specialty
Obsterics and gynecology Radiology Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of the negative-balance isolated pelvic perfusion for uterine cervical cancer which is inoperable or recurred after surgery, and resistant to conventional chemo-/chemoradiation therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of dose limiting toxicity in dose-ranging study
Objective response rate 6 months after the first NIPP session with the recommended dose
Key secondary outcomes Objective response rate 6 months after the.first NIPP session
Progression free survival
Overall survival
Time to treatment failure
Estimation of maximum tolerated dose
Incidence of neuropathy
Drug extraction rate
Correlation between serum cisplatin concentration and pelvic volume in each dose

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 Device,equipment
Interventions/Control_1 Perform two sessions of negative-balance isolated pelvic perfusion using intraarterial preparation of cisplatin (IA-call) with dose of 130, 150, 170, and 190mg/m2 (dose-ranging study)
Extract cisplatin using drug-extraction system after pelvic perfusion
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) Patients with inoperable or recurrent uterine cervical cancer after surgery which is resistant to chemotherapy or chemoradiation therapy
2) ECOG performance status score between 0 and 2
3) No brain or pulmonary metastasis
4) No major morbidity: neutrocyte above 500/mm3, hemoglobin above 7.0g/dL, platelet count above 50000/mm3, and serum creatinine persistently below 1.2 mg/dL
5) Written informed consent from the patient
Key exclusion criteria 1) Initial conventional therapy was not performed although indicated.
2) No measurable lesion according to RECIST ver 1.1
3) History of severe allergic reaction to iodine contrast media or platinum derivatives.
4) Impossible to catheterize due to hostile vascular anatomy
5) Contraindication to general anesthesia
6) History of heparin-induced thrombocytopenia
7) Presence of uncontrolled multiple neoplasm
8) Interstitial pneumonitis, pulmonary fibrosis, advanced emphysema, uncontrolled diabetes mellitus, uncontrolled hypertension, severe cardiac disease (heart failure, myocardial infarction, angina pectoris, etc...) with marked ECG abnormality, persistent adverse events (CTCAE ver 4.0 Grade 3 or worse)
9) Contraindication to drugs used in this study
10) Patients whom chief researcher or associate researcher judges unsuitable for this study
Target sample size 27

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Murata
Organization Nippon medical school hospital
Division name Radiology
Zip code
Address Sendagi 1-1-5, Bunkyo-ku, Tokyo, Japan
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 hospital
Division name Radiology
Zip code
Address Sendagi 1-1-5, Bunkyo-ku, Tokyo, Japan
TEL 03-3822-2131
Homepage URL
Email genji@nms.ac.jp

Sponsor
Institute Nippon medical school hospital
Institute
Department

Funding Source
Organization COSMOTEC Co., Ltd.
Kawasumi Laboratories. Inc.
Organization
Division
Category of Funding Organization Profit organization
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 YES
Study ID_1 NMS_CCR_NIPP1601
Org. issuing International ID_1 Nippon medical school hospital Center for Clinical Research
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 日本医科大学付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 05 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
2016 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 11 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 12 Month 21 Day
Last modified on
2016 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028665

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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