Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas

• Sponsor: Xuesong Li (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02547350
• Collaborator: (none)
• Enrollment: 200
• Arms: 3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of prophylactic intravesical chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC).

Condition or Disease	Intervention/Treatment	Phase
Upper Tract Urothelial Carcinoma; Bladder Recurrence	Drug: pharmorubicin or pirarubicin	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Sep 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Blank control do not use prophylactic intravesical chemotherapy
Experimental: single intravesical instillation intravesical instillation within 24 hours postoperatively	Drug: pharmorubicin or pirarubicin; pharmorubicin 50mg pirarubicin 30mg
Experimental: multiple intravesical instillation intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months	Drug: pharmorubicin or pirarubicin; pharmorubicin 50mg pirarubicin 30mg

Outcome Measures

Primary Outcome Measures

1. intravesical recurrence-free survival [two years after surgery]

Secondary Outcome Measures

1. cancer-specific survival [two years after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients who were clinically diagnosed with UTUC

2. Treated with radical nephroureterectomy

Exclusion Criteria:

1. Distant metastasis

2. Prior history of bladder or synchronous bladder cancer

3. Administration of neoadjuvant chemotherapy

4. Presence of severe complications.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Xuesong Li

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xuesong Li, professor, Peking University First Hospital
• ClinicalTrials.gov Identifier: NCT02547350
• Other Study ID Numbers: PIC-UTUC
• First Posted: Sep 11, 2015
• Last Update Posted: Sep 11, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Transitional Cell; Recurrence; Pirarubicin; Epirubicin

Study Results

No Results Posted as of Sep 11, 2015