NCT05295992Active, not recruiting
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 · Last updated 6 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 4 Mar 2022
- Start date
- 15 Mar 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Diseases
- Bladder cancer
- NCT number
- NCT05295992
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 15 Mar 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiation therapy
Other illness
- Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease)
Other
- Inability to comply with the protocol
- Presence of a hip prothesis
- Grade 2 or greater baseline diarrhea
Who the study is looking for
- Histologically proven bladder cancer
- Urothelial carcinoma
- Age ≥ 18 years
- Stage T1b-T4AN0M0
- TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion
- Suitable for radiotherapy
- ECOG/WHO performance status 0-2
- Written informed consent
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herlev and Gentofte Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.