Phase 1 clinical trial on the safety and efficacy of the negative-balance isolated pelvic perfusion (NIPP) for pelvic malignancy (uterine cervical cancer)

Phase 1 clinical trial on the safety and efficacy of the negative-balance isolated pelvic perfusion (NIPP) for pelvic malignancy (uterine cervical cancer) - NIPP phase 1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025351

Enrollment

Registered

2017-01-05

Start date

2016-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine cervical cancer

Interventions

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 cispla

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Incidence of dose limiting toxicity in dose-ranging study Objective response rate 6 months after the first NIPP session with the recommended dose	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactSatoru Murata

Nippon medical school hospital Radiology

genji@nms.ac.jp03-3822-2131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026