Clinical trial · Interventional
Adjuvant Post-radical Cystectomy Treatment for Bladder Cancer
NCT01734798CI-TRIAL-00008548completedPhase 3ClinicalTrials.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)
Radical Cystectomy is still the standard treatment in muscle-invasive Bladder cancer. Local recurrence is still the major cause of failure together with distant metastasis. postoperative radiotherapy succeeded to decrease the local recurrence and hence improved the overall survival. Adjuvant chemotherapy has also improved the survival in different studies. This study is performed to test the efficacy and toxicity of adding the two modalities together compared to each modality alone.
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 |
|---|---|---|---|
| Locally Advanced Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine and cisplatin | Drug | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
| Radiotherapy and Drug | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- post-operative radiotherapy will be done in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy Dose of Radiotherapy: 45 Gray Gy/30 fractions/3 weeks
- interventionNames
- Radiation: Radiation
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- adjuvant chemotherapy (gemcitabine and cisplatin) in addition to post operative radiotherapy in locally advanced bladder cancer patients (P3b, P4a, G3 and / or LN positive patients) after radical cystectomy
- interventionNames
- Other: Radiotherapy and Drug
- type
- EXPERIMENTAL
- label
- Arm 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients not more than 70 years old. * Radical cystectomy performed within 42 days with no microscopic or macroscopic residual after surgery (negative surgical safety margins) * Having one or more of the risk factors ( P3b,P4a,G3 and /or positive LN) * ECOG Performance Scale (0-2). * Adequate liver functions. * Adequate renal function serum (creatinine \< 1.5 mg). * No evidence of distant metastasis or other malignancy. Exclusion Criteria: * patients who received radiotherapy or chemotherapy prior to radical cystectomy
References
Publications (1)
- DERIVEDZaghloul MS, Christodouleas JP, Smith A, Abdallah A, William H, Khaled HM, Hwang WT, Baumann BC. Adjuvant Sandwich Chemotherapy Plus Radiotherapy vs Adjuvant Chemotherapy Alone for Locally Advanced Bladder Cancer After Radical Cystectomy: A Randomized Phase 2 Trial. JAMA Surg. 2018 Jan 17;153(1):e174591. doi: 10.1001/jamasurg.2017.4591. Epub 2018 Jan 17. PMID 29188298