Clinical trial · Interventional
Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer
Phase 1-2 Study of the Association of Gemzar ® - Cisplatin-concurrent Radiotherapy in Patients With Non-metastatic Tumors of the Bladder
- 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 gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with cisplatin and radiation therapy and to see how well they work in treating patients with stage II or stage III 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| cystoscopy | Procedure | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- gemcitabine, cisplatine, radiotherapy
- interventionNames
- Drug: cisplatin
- Drug: gemcitabine hydrochloride
- Procedure: biopsy
- Procedure: cystoscopy
- Procedure: therapeutic conventional surgery
- Radiation: radiation therapy
Primary outcomes (2)
- measure
- Incidence and nature of acute and late toxicity (Phase I)
- timeFrame
- From baseline to the end of treatment
- measure
- Local tumor control (Phase II)
- timeFrame
- From baseline to the end of treatment
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of muscle invasive transitional cell carcinoma of the bladder * T2-4a, N0, M0 (stage II or III disease) * No adenocarcinoma or squamous cell carcinoma PATIENT CHARACTERISTICS: * WHO performance status (PS) 0-2 or Karnofsky PS 70-100% * Life expectancy ≥ 6 months * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL * Creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception during and for at least 2 months after completion of study treatment * No other prior malignancy, except previously treated nonmalignant skin cancer or carcinoma in situ of the cervix * No prior serious digestive complications (e.g., ulcerative colitis or complicated diverticulosis) PRIOR CONCURRENT THERAPY: * No prior radiotherapy or chemotherapy (except for intravesical instillations)
References
Publications (0)
Data not yet available