Clinical trial · Interventional
Carboplatin-gemcitabine Versus Cisplatin- Gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer
Carboplatin-gemcitabine Versus Cisplatin-gemcitabine as Neoadjuvant Chemotherapy for Treatment of Muscle Invasive Urinary Bladder Cancer: a Prospective Randomized Trial
- 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)
Patients will be randomized in 1:1 ratio to two treatment groups first group will receive 3-4 cycles of neoadjuvant Carboplatin(AUC4)-Gemcitabine (treatment group) and second group will receive 3-4 cycles of neoadjuvant Cisplatin(75mg/m2 Day1)-Gemcitabine (Control group). Patients will undergo radiological assessment, full laboratory work up, and cystoscopy before undergoing either radical cystectomy or Definitive Radiotherapy concurrent with chemotherapy
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 |
|---|---|---|---|
| Urinary Bladder Cancer | Malignant Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin-Gemcitabine Cisplatin-Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Carboplatin-gemcitabine
- description
- 3-4 cycles of Carboplatin-Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive
- interventionNames
- Drug: Carboplatin-Gemcitabine Cisplatin-Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- cisplatin-gemcitabine
- description
- 3-4 cycles of Cisplatin -Gemcitabine as a neoadjuvant treatment for Urinary bladder cancer Muscle invasive
- interventionNames
- Drug: Carboplatin-Gemcitabine Cisplatin-Gemcitabine
Primary outcomes (1)
- measure
- Clinical response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:All patients diagnosed with muscle invasive urinary bladder cancer that can receive chemotherapy are included the criteria are * • Age above 18 years, * Pathologically proven urinary bladder cancer, * Patients with clinical stages T2-4a N0-3 M0, * Patients with good renal and liver functions * patients with no distant metastases, * no other malignancy (double malignancy). * Performance status 0-1 according to ECOG performance status scale. * Patients with no contraindications for radiotherapy. Exclusion Criteria: * • performance status 2-4 according to ECOG performance status scale. * patients refuse to receive chemotherapy, * patients not eligible to receive chemotherapy due to liver or renal impairment or thrombocytopenia, * patients with M1 disease.
References
Publications (0)
Data not yet available