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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
Herlev and Gentofte Hospital
Herlev, Denmark
Early Rate CTCAE GI Toxicity
Change of the peak early rate of external beam radiation therapy treatment-related (CTCAE) grade 2+ diarrhea
Time frame: Start of radiotherapy to 3 months after end of radiotherapy
All Early CTCAE Treatment Related Toxicities
All early adaptive radiation therapy treatment related CTCAE grade 2 and above toxicity
Time frame: From start of radiotherapy through 3 months after end of radiotherapy
All Late CTCAE Treatment Related Toxicities
All late CTCAE adaptive radiation therapy treatment related toxicity grade 2 and above
Time frame: From 3 months after end of radiotherapy through 2 years follow-up
Patient Reported Outcomes (PRO)
Collection of NCI PRO-CTCAE questionnaire
Time frame: Baseline through 2 year follow-up
EORTC Quality of Life Assessment
Collection of EORTC QLQ C30
Time frame: Baseline through 2 year follow-up
EuroQol Quality of Life Assessment
Collection EQ-5D-5L questionnaires
Time frame: Baseline through 2 year follow-up
Local Progression Free Survival
Local progression free survival
Time frame: From time of inclusion to local progression, assessed up to 24 months post treatment
Local Control
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Local control (freedom from local progression)
Time frame: At 12 and 24 months
Progression Free Survival
Progression free survival (from time of inclusion to disease progression)
Time frame: From time of inclusion to disease progression, assessed up to 24 months post treatment
Overall Survival
Overall survival
Time frame: From time of inclusion to death from any cause, assessed up to 24 months post treatment
Disease Free Survival
Disease Free Survival
Time frame: 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
Time frame: 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
Time frame: From start of radiation therapy through end of external beam treatment (approximately 6 weeks)