UMIN-CTR Clinical Trial

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