Adaptive radiation therapy for muscle-invasive bladder cancer
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)
This study is testing if a personalized radiation therapy can help reduce stomach and bowel side effects for people with muscle-invasive bladder cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Varian, a Siemens Healthineers Company Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Herlev) |
| Trial ID | NCT05295992 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of adaptive radiation therapy in reducing acute gastrointestinal toxicity in patients with muscle-invasive bladder cancer. It is a single-arm, prospective, Phase II trial conducted across multiple centers. Participants will receive Varian Ethos Adaptive Radiation Therapy, which is designed to tailor treatment based on individual patient needs. The study compares the outcomes of this adaptive approach to historical data from non-adaptive intensity modulated radiation therapy (IMRT).
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically proven muscle-invasive bladder cancer who are suitable for radiotherapy.
Not a fit: Patients with prior pelvic radiation therapy or uncontrolled inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced gastrointestinal side effects for patients undergoing treatment for bladder cancer.
How similar studies have performed: Other studies have shown promise with adaptive radiation therapy, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Herlev
- Herlev and Gentofte Hospital — Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Katrine Storm, MD — Herlev Hospital, Copenhagen University
- Study coordinator: Steve Kohlmyer, MS
- Email: steve.kohlmyer@varian.com
- Phone: 12062760076
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.