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| Name | Class |
|---|---|
| Herlev Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Adaptive External Beam Radiation Therapy | Experimental | Daily adaptive radiation therapy delivered with Varian Ethos treatment system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varian Ethos Adaptive Radiation Therapy | Device | Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| All Late CTCAE Treatment Related Toxicities |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrine Storm, MD | Herlev Hospital, Copenhagen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte Hospital | Herlev | DK-2730 | Denmark |
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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 |
| Patient Reported Outcomes (PRO) | Collection of NCI PRO-CTCAE questionnaire | Baseline through 2 year follow-up |
| EORTC Quality of Life Assessment | Collection of EORTC QLQ C30 | Baseline through 2 year follow-up |
| EuroQol Quality of Life Assessment | Collection EQ-5D-5L questionnaires | Baseline through 2 year follow-up |
| Local Progression Free Survival | Local progression free survival | From time of inclusion to local progression, assessed up to 24 months post treatment |
| Local Control | Local control (freedom from local progression) | At 12 and 24 months |
| 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 |
| Overall Survival | Overall survival | From time of inclusion to death from any cause, assessed up to 24 months post treatment |
| Disease Free Survival | Disease Free Survival | From time of inclusion to death from bladder cancer, assessed up to 24 months post treatment |
| Treatment Related Hospitalization | Hospitalization due to adaptive radiation therapy treatment related toxicity | From of start of radiation therapy through 2 year follow-up |
| 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) |