Clinical trial · Interventional
Neoadjuvant Ifosfamide, Doxorubicin, Gemcitabine, and Cisplatin in Treating Patients Who Are Undergoing Radical Cystectomy for Locally Advanced Carcinoma (Cancer) of the Urothelium
Phase II Trial of Neoadjuvant, Multi-Agent Chemotherapy For Locally Advanced Urothelial Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, doxorubicin, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well neoadjuvant combination chemotherapy works in treating patients undergoing radical cystectomy for locally advanced carcinoma of the urothelium.
Conditions
Conditions (3)
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 |
| Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Urethral Cancer | Malignant Urethral Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Response rate
- timeFrame
- 6 weeks following treatment
- measure
- Disease-free survival at 4 years
- timeFrame
- 4 years
Secondary outcomes (1)
- measure
- Comparison of perioperative treatment morbidity and mortality with historical standards
- timeFrame
- Minimally reviewed following 6 weeks post treatment
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed carcinoma of the urothelium, meeting 1 of the following criteria for locally advanced disease: * Clinical stage T3b disease, defined by presence of a mass on examination under anesthesia * Clinical stage T4a disease, defined by direct invasion of prostatic stroma, vagina, or rectum * Lymphovascular invasion on transurethral resection specimen * Upper tract disease or micropapillary histology allowed * No evidence of disease outside the pelvis PATIENT CHARACTERISTICS: Age * Any age Performance status * 0-2 Life expectancy * Not specified Hematopoietic * Bone marrow function adequate Hepatic * Liver function adequate Renal * Creatinine clearance ≥ 45 mL/min Cardiovascular * Ejection fraction ≥ 50% Other * Not pregnant * No other malignancy likely to be life-threatening within the next 4 years PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * See Disease Characteristics
References
Publications (0)
Data not yet available