Clinical trial · Interventional
Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
Phase II Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed due to poor accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine whether sutent (sunitinib)is effective in preventing tumor recurrence in patients with high risk bladder cancer who have previously had chemotherapy and cystectomy (bladder removal). A 4 month supply of the drug is given to patients beginning 2-3 months after bladder removal. The patients are followed up to 2 years.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Continuous Daily Dosing of Sunitinib
- interventionNames
- Drug: Sunitinib
Primary outcomes (1)
- measure
- Disease Free Survival
- timeFrame
- 2- year
- description
- 2-year disease free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of bladder carcinoma (\>50% urothelial carcinoma) * Prior treatment with at least one cycle of platin-based neoadjuvant chemotherapy * Prior treatment with radical cystectomy revealing pT3NxM0 or pTanyN+M0 * ECOG performance status of 0-1 (Appendix 2). * No evidence of metastases within 4 weeks of registration * Adequate organ and marrow function obtained within 14 days of registration Exclusion Criteria: * Severe or uncontrolled acute or chronic medical or psychiatric condition * Prior antiangiogenic therapy * Prior pelvic radiation for bladder cancer
References
Publications (0)
Data not yet available