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Randomized Phase II trial of single early intravesical administration of THP for prevention of recurrent bladder tumors following surgery for upper urinary tract urotherial tumors.

Randomized Phase II trial of single early intravesical administration of THP for prevention of recurrent bladder tumors following surgery for upper urinary tract urotherial tumors. - THPMG

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004039
Enrollment
50
Registered
2010-08-13
Start date
2006-01-01
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

Upper urinary tract urotherial tumor

Interventions

intravesical administration of THP control

Sponsors

Tohoku University School of Medicine,Department of Urology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: We have to satisfy all the following basis. 1) The case that an agreement is obtained in a document about participation of the final examination 2) The case that it is diagnosed as upper urinary tract urotherial tumors pathologically 3) No previous treatments 4) No metastasis and radical operation 5) No concomitant bladder tumors and/or a previous history of bladder tumors 6) Patients who can take cystoscopy 7) ECOG performance status: 0-3 8) The case that follow-ups more than postoperative one year is possible at least 9) Patients who have adequate major organ functions and fulfill all of the following criteria 1.ALT (GPT)/AST(GOT) upper limit of normal range 2.serum Creatine <1.5mg/dl 3.WBC: more than 4,000/mm3 Hb: more than 10 mg/dL Plt: more than 100000/mm3 4.Electrocardiograph: Normal

Exclusion criteria

Exclusion criteria: 1)The patient having a grave complication 2) Active cancer except upper urinary tract urotherial tumors is the patient 3)In addition, the patient whom we intended for it, and it was judged judgment of a doctor to be inadequate

Design outcomes

Primary

MeasureTime frame
Bladder recurrence rate

Countries

Japan

Contacts

Public ContactAkihiro Ito

Tohoku University School of Medicine Department of Urology

Outcome results

None listed

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