Clinical trial · Interventional
Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach
Daily Online Adaptive Radiation Therapy of Bladder Cancer for Reduction of Intestinal Toxicity: A Prospective Trial Using an Individualized Approach and Conventional Fractionation (ARTIA-Vesica)
- 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)
This is a single-arm, prospective, Phase II, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle invasive bladder cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).
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 |
|---|---|---|---|
| Muscle-Invasive Bladder Carcinoma | Muscle Invasive Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Varian Ethos Adaptive Radiation Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Daily Adaptive External Beam Radiation Therapy
- description
- Daily adaptive radiation therapy delivered with Varian Ethos treatment system.
- interventionNames
- Device: Varian Ethos Adaptive Radiation Therapy
Primary outcomes (1)
- measure
- Early Rate CTCAE GI Toxicity
- timeFrame
- Start of radiotherapy to 3 months after end of radiotherapy
- description
- Change of the peak early rate of external beam radiation therapy treatment-related (CTCAE) grade 2+ diarrhea
Secondary outcomes (12)
- measure
- All Early CTCAE Treatment Related Toxicities
- timeFrame
- From start of radiotherapy through 3 months after end of radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven bladder cancer 2. Urothelial carcinoma 3. Age ≥ 18 years 4. Stage T1b-T4AN0M0 5. TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion 6. Suitable for radiotherapy 7. ECOG/WHO performance status 0-2 8. Written informed consent 9. For Cohort B, participant's must have normal organ and marrow function as defined below: * leukocytes ≥2,500/mcL * absolute neutrophil count ≥1,500/mcL * platelets ≥100,000/mcL * hemoglobin ≥9 g/dL * total bilirubin ≤ 1,5 ULN * AST(SGOT)/ALT(SGPT) ≤3 × ULN * alkaline phosphatase ≤2.5 × ULN * creatinine clearance \<25 ml/min We recommend avoiding cisplatin for participants with creatinine clearance \<50 ml/min. * INR and aPTT £1.5 ULN Exclusion Criteria: 1. Prior pelvic radiation therapy 2. Inability to comply with the protocol 3. Presence of a hip prothesis 4. Grade 2 or greater baseline diarrhea 5. Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease)
References
Publications (0)
Data not yet available