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Phase 1 and 2 study on Negative-balance isolated pelvic perfusion

Phase 1 and 2 study on Negative-balance isolated pelvic perfusion - Phase 1 and 2 study on NIPP

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012151
Enrollment
60
Registered
2013-10-29
Start date
2013-10-29
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

Advanced bladder cancer Advanced uterine cancer Recurrent rectal cancer

Interventions

Establish isolated pelvic perfusion using balloon catheters. Perform the procedure more than twice, more than 2 weeks apart. Initial dose is cisplatin 190mg/m2 plus 5-FU 2000mg/m2 for bladder cancer,

Sponsors

Nippon medical school
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. No indication of surgical resection 3. Apparent increase in tumor size after performing chemotherapy and radiation therapy according to a standard protocol 4. Performance status of 0-2 according to the Eastern Cooperative Oncology Group (ECOG) score 5. Acceptable renal function (serum creatinine less than 1.2 mg/dl) 6. Acceptable bone marrow function (leukocyte count 3500/mm3 or more, and platelet count 50000/mm3 or more).

Exclusion criteria

Exclusion criteria: 1. Contraindication to angiography (due to severe side effect of contrast media) 2. High risk for general anesthesia 3. Severe comorbidities 4. Vascular anatomy not suitable for catheterization

Design outcomes

Primary

MeasureTime frame
5-year survival rate Progression free survival Antitumor effect (RECIST) Adverse events (CTCAE grade) within 4 weeks after treatment

Secondary

MeasureTime frame
Performance status Visual analog scale

Countries

Japan,North America,Europe

Contacts

Public ContactSatoru Murata

Nippon medical school Department of Radiology

genji@nms.ac.jp03-3822-2131

Outcome results

None listed

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