Clinical trial · Interventional
Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
Chemoresection With 4 Weekly Intravesical Instillations Of Mitomycin C Versus Transurethral Resection (TUR) Followed By One Single Immediate Instillation Of Mitomycin C In Single, Small, Papillary Stage Ta, T1 Bladder Tumors: A Prospective Randomized Phase III Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing chemotherapy drugs directly into the bladder may kill more cancer cells. It is not yet known if surgery followed by chemotherapy is more effective than chemotherapy alone in treating bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy alone with that of transurethral resection followed by chemotherapy in treating patients who have bladder cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| mitomycin C | Drug | Mitomycin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Cytologically confirmed solitary primary or recurrent papillary transitional cell carcinoma of the bladder * Ta or T1 * Tumor no greater than 2 cm in diameter * Negative urine cytology * No suspicious lesions in bladder requiring biopsy * No tumors in the prostatic urethra or upper urinary tract * No prior history of T1 G3 tumors, muscle invasive tumors (T2 or greater), or carcinoma in situ PATIENT CHARACTERISTICS: Age * 80 and under Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * HIV negative * No active intractable or uncontrollable bladder infection * No urethral strictures that would preclude endoscopic procedures or repeated catheterization * No prior or concurrent congenital or acquired immune deficiency syndrome * No other prior or concurrent malignancy except cured basal cell skin cancer or intraepithelial cancer of the cervix * No prior or concurrent leukemia or Hodgkin's disease * No concurrent disease for which general anesthesia is contraindicated * No psychological, familial, sociological, or geographical condition that would preclude study compliance * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy * More than 12 months since prior BCG vaccine Chemotherapy * At least 1 year since prior mitomycin Endocrine therapy * Not specified Radiotherapy * No prior pelvic radiotherapy Surgery * No prior organ transplant Other * At least 3 months since prior intravesical treatment
References
Publications (0)
Data not yet available