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A phase I/II study of percutaneous radiofrequency ablation for malignant tumor in the pelvis (JIVROSG-0204)

A phase I/II study of percutaneous radiofrequency ablation for malignant tumor in the pelvis (JIVROSG-0204) - Percutaneous radiofrequency ablation for intrapelvic tumor (JIVROSG-0204)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000046
Enrollment
33
Registered
2005-08-06
Start date
2005-06-01
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

Symptomatic intrapelvic malignant tumor

Interventions

Radiofrequency ablation needle is percutaneouly inserted into the intrapelvic malignant tumor and radiofrequency ablation is performed.

Sponsors

Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Symptomatic and uncontrollable intrapelvic malignant tumor. 2) Histologically confirmed malignant lesion. 3) Maximum diameter of lesion on image not exceed 5cm. 4) No influence of previous treatment. 5) Measurable disease on CT or MRI. 6) Any ascites in Douglas pouch allowed. 7) Lesion mainly located in intrapelvic space. 8) Adequate cardiac, hepatic, renal, respiratory, coagulation, and bone marrow functions. 9) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3. 10) Expected survival more than 4 weeks. 11) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) No symptom or VAS of less than 3. 2) Cardiac pacemaker. 3) Artery or nerve along the puncture route. 4) Lesion or target area adjacent to critical organs. 5) Infection in the target area. 6) Pregnancy.

Design outcomes

Primary

MeasureTime frame
Adverse events

Secondary

MeasureTime frame
Improvement of symptom measured by Visual Analogue Scale at 1 week after the procedure.

Countries

Japan

Contacts

Public ContactYasuaki Arai

JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital

jivrosgoffice@ml.res.ncc.go.jp03-3542-2511

Outcome results

None listed

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