UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025351 |
|---|---|
| Receipt number | 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 | 2020/09/29 08:47:07 |
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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
| Obstetrics 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
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
genji@nms.ac.jp
Sponsor or person
Institute
Nippon medical school hospital
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 23 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 23 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 21 | Day |
Last modified on
| 2020 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028665
