Clinical trial · Interventional
Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
A Phase I/II Trial in Patients With Muscle-Invading Bladder Cancer of Transurethral Surgery Plus Taxol, Cisplatin and Bid Irradiation Followed by Either Selective Bladder Preservation or Radical Cystectomy and Adjuvant Chemotherapy
NCT00003930CI-TRIAL-00047768completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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: Radiation therapy uses x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy and surgery may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer that can be removed by surgery.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Transurethral surgery with chemotherapy and radiation therapy followed by either selective bladder preservation or radical cystectomy followed by adjuvant chemotherapy.
- interventionNames
- Drug: cisplatin
- Drug: gemcitabine hydrochloride
- Drug: paclitaxel
- Procedure: conventional surgery
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Completion and safety of induction chemo-radiotherapy followed by definitive local therapy of either radical cystectomy or consolidation TCI, followed by four cycles of outpatient adjuvant gemcitabine-cisplatin chemotherapy.
- timeFrame
- From start to end of all protocol therapy
- description
- Completion and safety of induction chemo-radiotherapy (cisplatin, paclitaxel and irradiation \[TCI\]) followed by definitive local therapy of either radical cystectomy (for patients for whom the initial tumor is not a complete response) or consolidation TCI (for patients for whom the initial tumor has cleared), followed by four cycles of outpatient adjuvant gemcitabine-cisplatin chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage II or III (T2-4a, Nx or N0, M0) primary carcinoma of the bladder with muscle invasion * Resectable disease * Prostatic urethral involvement with transitional cell carcinoma allowed, if completely resected and no evidence of stromal invasion * No tumor-related hydronephrosis * Positive lymph node must be evaluated by lymphadenectomy or percutaneous needle biopsy * No nodal metastases * No distant metastases * No more than 6 weeks since prior transurethral resection of the bladder tumor * Functioning bladder PATIENT CHARACTERISTICS: Age: * Adult Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Hemoglobin at least 10 g/dL * White blood cell (WBC) count of at least 4,000/mm\^3 * Absolute neutrophil count at least 1,800/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL Renal: * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min Other: * No other prior or concurrent malignancy within the past 5 years except curatively treated nonmelanoma skin cancer, stage I prostate cancer, or carcinoma in situ of the cervix * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * Medically operable PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior pelvic radiotherapy Surgery: * See Disease Characteristics Other: * No concurrent potential nephrotoxic or ototoxic drugs (e.g., aminoglycosides)
References
Publications (4)
- BACKGROUNDEfstathiou JA, Bae K, Shipley WU, Kaufman DS, Hagan MP, Heney NM, Sandler HM. Late pelvic toxicity after bladder-sparing therapy in patients with invasive bladder cancer: RTOG 89-03, 95-06, 97-06, 99-06. J Clin Oncol. 2009 Sep 1;27(25):4055-61. doi: 10.1200/JCO.2008.19.5776. Epub 2009 Jul 27. PMID 19636019
- RESULTKaufman DS, Winter KA, Shipley WU, Heney NM, Wallace HJ 3rd, Toonkel LM, Zietman AL, Tanguay S, Sandler HM. Phase I-II RTOG study (99-06) of patients with muscle-invasive bladder cancer undergoing transurethral surgery, paclitaxel, cisplatin, and twice-daily radiotherapy followed by selective bladder preservation or radical cystectomy and adjuvant chemotherapy. Urology. 2009 Apr;73(4):833-7. doi: 10.1016/j.urology.2008.09.036. Epub 2008 Dec 18. PMID 19100600
- RESULTKaufman DS, Winter KA, Shipley WU, et al.: Muscle-invading bladder cancer, RTOG Protocol 99-06: initial report of a phase I/II trial of selective bladder-conservation employing TURBT, accelerated irradiation sensitized with cisplatin and paclitaxel followed by adjuvant cisplatin and gemcitabine chemotherapy. [Abstract] J Clin Oncol 23 (Suppl 16): A-4506, 379s, 2005.
- DERIVEDMak RH, Hunt D, Shipley WU, Efstathiou JA, Tester WJ, Hagan MP, Kaufman DS, Heney NM, Zietman AL. Long-term outcomes in patients with muscle-invasive bladder cancer after selective bladder-preserving combined-modality therapy: a pooled analysis of Radiation Therapy Oncology Group protocols 8802, 8903, 9506, 9706, 9906, and 0233. J Clin Oncol. 2014 Dec 1;32(34):3801-9. doi: 10.1200/JCO.2014.57.5548. Epub 2014 Nov 3. PMID 25366678