Clinical trial NCT05295992: Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach
Official title: Daily Online Adaptive Radiation Therapy of Bladder Cancer for Reduction of Intestinal Toxicity: A Prospective Trial Using an Individualized Approach and Conventional Fractionation (ARTIA-Vesica)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscle-Invasive Bladder Carcinoma
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
Collaborators: name: Herlev Hospital
name: Rigshospitalet, Denmark
First posted: 2022-03-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Early Rate CTCAE GI Toxicity
timeFrame: Start of radiotherapy to 3 months after end of radiotherapy
Secondary outcomes:
measure: All Early CTCAE Treatment Related Toxicities
timeFrame: From start of radiotherapy through 3 months after end of radiotherapy
measure: All Late CTCAE Treatment Related Toxicities
timeFrame: From 3 months after end of radiotherapy through 2 years follow-up
measure: Patient Reported Outcomes (PRO)
timeFrame: Baseline through 2 year follow-up
measure: EORTC Quality of Life Assessment
timeFrame: Baseline through 2 year follow-up
measure: EuroQol Quality of Life Assessment
timeFrame: Baseline through 2 year follow-up
measure: Local Progression Free Survival
timeFrame: From time of inclusion to local progression, assessed up to 24 months post treatment
measure: Local Control
timeFrame: At 12 and 24 months
measure: Progression Free Survival
timeFrame: From time of inclusion to disease progression, assessed up to 24 months post treatment
measure: Overall Survival
timeFrame: From time of inclusion to death from any cause, assessed up to 24 months post treatment
measure: Disease Free Survival
timeFrame: From time of inclusion to death from bladder cancer, assessed up to 24 months post treatment
measure: Treatment Related Hospitalization
timeFrame: From of start of radiation therapy through 2 year follow-up
measure: Workflow Feasibility
timeFrame: From start of radiation therapy through end of external beam treatment (approximately 6 weeks)
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
Study officials:
affiliation: Herlev Hospital, Copenhagen University
name: Katrine Storm, MD
role: PRINCIPAL_INVESTIGATOR
References: