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

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 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


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

Value
https://center6.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