Muscle-Invasive Bladder Carcinoma
Conditions
Brief summary
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).
Interventions
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
Sponsors
Varian, a Siemens Healthineers Company
Herlev Hospital
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Rate CTCAE GI Toxicity | Start of radiotherapy to 3 months after end of radiotherapy | Change of the peak early rate of external beam radiation therapy treatment-related (CTCAE) grade 2+ diarrhea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Early CTCAE Treatment Related Toxicities | From start of radiotherapy through 3 months after end of radiotherapy | All early adaptive radiation therapy treatment related CTCAE grade 2 and above toxicity |
| All Late CTCAE Treatment Related Toxicities | From 3 months after end of radiotherapy through 2 years follow-up | All late CTCAE adaptive radiation therapy treatment related toxicity grade 2 and above |
| Patient Reported Outcomes (PRO) | Baseline through 2 year follow-up | Collection of NCI PRO-CTCAE questionnaire |
| EORTC Quality of Life Assessment | Baseline through 2 year follow-up | Collection of EORTC QLQ C30 |
| EuroQol Quality of Life Assessment | Baseline through 2 year follow-up | Collection EQ-5D-5L questionnaires |
| Local Progression Free Survival | From time of inclusion to local progression, assessed up to 24 months post treatment | Local progression free survival |
| Local Control | At 12 and 24 months | Local control (freedom from local progression) |
| Progression Free Survival | From time of inclusion to disease progression, assessed up to 24 months post treatment | Progression free survival (from time of inclusion to disease progression) |
| Overall Survival | From time of inclusion to death from any cause, assessed up to 24 months post treatment | Overall survival |
| Disease Free Survival | From time of inclusion to death from bladder cancer, assessed up to 24 months post treatment | Disease Free Survival |
| Treatment Related Hospitalization | From of start of radiation therapy through 2 year follow-up | Hospitalization due to adaptive radiation therapy treatment related toxicity |
| Workflow Feasibility | From start of radiation therapy through end of external beam treatment (approximately 6 weeks) | Record percentage of fractions delivered with adaptive radiation therapy vs traditional IGRT |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORKatrine Storm, MD
Herlev Hospital, Copenhagen University
Outcome results
None listed