Muscle-Invasive Bladder Carcinoma Clinical Trial
— ARTIA-VesicaOfficial title:
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)
NCT number | NCT05295992 |
Other study ID # | VAR-2021-06 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 15, 2022 |
Est. completion date | March 2026 |
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 | Recruiting |
Enrollment | 110 |
Est. completion date | March 2026 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev and Gentofte Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Varian, a Siemens Healthineers Company | Herlev Hospital, Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Early Rate CTCAE GI Toxicity | Change of the peak early rate of external beam radiation therapy treatment-related (CTCAE) grade 2+ diarrhea | Start of radiotherapy to 3 months after end of radiotherapy | |
Secondary | All Early CTCAE Treatment Related Toxicities | All early adaptive radiation therapy treatment related CTCAE grade 2 and above toxicity | From start of radiotherapy through 3 months after end of radiotherapy | |
Secondary | All Late CTCAE Treatment Related Toxicities | All late CTCAE adaptive radiation therapy treatment related toxicity grade 2 and above | From 3 months after end of radiotherapy through 2 years follow-up | |
Secondary | Patient Reported Outcomes (PRO) | Collection of NCI PRO-CTCAE questionnaire | Baseline through 2 year follow-up | |
Secondary | EORTC Quality of Life Assessment | Collection of EORTC QLQ C30 | Baseline through 2 year follow-up | |
Secondary | EuroQol Quality of Life Assessment | Collection EQ-5D-5L questionnaires | Baseline through 2 year follow-up | |
Secondary | Local Progression Free Survival | Local progression free survival | From time of inclusion to local progression, assessed up to 24 months post treatment | |
Secondary | Local Control | Local control (freedom from local progression) | At 12 and 24 months | |
Secondary | Progression Free Survival | Progression free survival (from time of inclusion to disease progression) | From time of inclusion to disease progression, assessed up to 24 months post treatment | |
Secondary | Overall Survival | Overall survival | From time of inclusion to death from any cause, assessed up to 24 months post treatment | |
Secondary | Disease Free Survival | Disease Free Survival | From time of inclusion to death from bladder cancer, assessed up to 24 months post treatment | |
Secondary | Treatment Related Hospitalization | Hospitalization due to adaptive radiation therapy treatment related toxicity | From of start of radiation therapy through 2 year follow-up | |
Secondary | Workflow Feasibility | Record percentage of fractions delivered with adaptive radiation therapy vs traditional IGRT | From start of radiation therapy through end of external beam treatment (approximately 6 weeks) |
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