Clinical trial · Interventional
Prospective Study of Adjuvant Radiotherapy in High Risk Bladder Cancer.
NCT03718741CI-TRIAL-00058348Bladder-AidterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): few patients enrolled
Summary
Brief summary (as posted)
This prospective interventional study aims at evaluating the safety and efficacy of an adjuvant radiation treatment in cases of muscle-invasive bladder cancer, submitted to radical cystectomy and presenting clinic-pathological characteristics of high risk of recurrence.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy +/- CT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adiuvant Radiotherapy +/- CT
- description
- The radiation treatment will be delivered with two possible schedules, according to the presence of positive margins on the pathology specimen: * R0: PTVb + PTVn 50 Gy in 25 fractions * R1-2: PTVn 50 Gy in 25 fractions. PTVb (including cystectomy bed and residual tumor when present) 55 Gy in 25 fractions with simultaneous integrated boost (SIB). Considering an alfa/beta of 10 for bladder tumor and 3 for healthy tissues the equivalent doses will be respectively: BED10: 60/67.1; EQD2: 50/55.92 Gy BED3: 83.33/95.33; EQD2: 50/57.20 Gy Patients with ECOG PS\<2, good haematological, hepatic and renal function (haemoglobin, neutrophil count, platelets, creatinine, glycaemia, Bilirubin, AST, ALT values within the limits of normal), will be submitted to concurrent cisplatin based weekly chemotherapy, 20-30 mg/m2, if they have not received neoadjuvant chemotherapy before surgery.
- interventionNames
- Radiation: Radiotherapy +/- CT
Primary outcomes (1)
- measure
- Local Control Rate
- timeFrame
- 2 year
- description
- This prospective interventional study aims at evaluating the safety and efficacy of an adjuvant radiation treatment in cases of muscle-invasive bladder cancer, submitted to radical cystectomy and presenting clinic-pathological characteristics of high risk of recurrence.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Karnofsky index \> 60 % (ECOG \< 2) * Histologically confirmed muscle-invasive bladder cancer (MIBC) submitted to radical cystectomy. * Pathological T-stage \> pT3, and/or pathological N-stage \> pN1, and/or residual tumor present after surgery (R\>1) * No distant metastases * Written informed consent Exclusion Criteria: * Prior RT in the pelvic region * Presence of distant metastases * Pregnancy * Inability to consent
References
Publications (0)
Data not yet available
No reference posted for this study.