Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach
NCT ID: NCT05295992
Last Updated: 2023-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2022-03-15
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Daily Adaptive External Beam Radiation Therapy
Daily adaptive radiation therapy delivered with Varian Ethos treatment system.
Varian Ethos Adaptive Radiation Therapy
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
Interventions
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Varian Ethos Adaptive Radiation Therapy
Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Herlev Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Varian, a Siemens Healthineers Company
INDUSTRY
Responsible Party
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Principal Investigators
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Katrine Storm, MD
Role: PRINCIPAL_INVESTIGATOR
Herlev Hospital, Copenhagen University
Locations
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Herlev and Gentofte Hospital
Herlev, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VAR-2021-06
Identifier Type: -
Identifier Source: org_study_id
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