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Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach

Not Applicable
Recruiting
Conditions
Muscle-Invasive Bladder Carcinoma
Registration Number
NCT05295992
Lead Sponsor
Varian, a Siemens Healthineers Company
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
110
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Early Rate CTCAE GI ToxicityStart 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 Outcome Measures
NameTimeMethod
Overall SurvivalFrom time of inclusion to death from any cause, assessed up to 24 months post treatment

Overall survival

Disease Free SurvivalFrom time of inclusion to death from bladder cancer, assessed up to 24 months post treatment

Disease Free Survival

Local Progression Free SurvivalFrom time of inclusion to local progression, assessed up to 24 months post treatment

Local progression free survival

Progression Free SurvivalFrom time of inclusion to disease progression, assessed up to 24 months post treatment

Progression free survival (from time of inclusion to disease progression)

Patient Reported Outcomes (PRO)Baseline through 2 year follow-up

Collection of NCI PRO-CTCAE questionnaire

EORTC Quality of Life AssessmentBaseline through 2 year follow-up

Collection of EORTC QLQ C30

EuroQol Quality of Life AssessmentBaseline through 2 year follow-up

Collection EQ-5D-5L questionnaires

Local ControlAt 12 and 24 months

Local control (freedom from local progression)

Workflow FeasibilityFrom 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

All Early CTCAE Treatment Related ToxicitiesFrom 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 ToxicitiesFrom 3 months after end of radiotherapy through 2 years follow-up

All late CTCAE adaptive radiation therapy treatment related toxicity grade 2 and above

Treatment Related HospitalizationFrom of start of radiation therapy through 2 year follow-up

Hospitalization due to adaptive radiation therapy treatment related toxicity

Trial Locations

Locations (1)

Herlev and Gentofte Hospital

🇩🇰

Herlev, Denmark

Herlev and Gentofte Hospital
🇩🇰Herlev, Denmark
Katrine Storm
Contact
katrine.smedegaard.storm@regionh.dk

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