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Adaptive Radiotherapy Using Plan Selection for Bladder Cancer: A Phase II Trial

Phase 2
18 Years
Open (Enrolling)
Adverse Effects for Adaptive RT of Bladder Cancer

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Trial Information

Adaptive Radiotherapy Using Plan Selection for Bladder Cancer: A Phase II Trial

After inclusion patients are asked about their adverse effects by an oncologist using CTCAE
(version 4.0) questionnaire. A planning CT-scan is acquired and for the first 10 patients
also a MR-scan for intra fractional motion is acquired. The MR sequence is repeated every
week during radiotherapy. The first week of treatment a standard non-adaptive IMRT-plan is
used and CBCT-scans are acquired before and after treatment. The CBCT-scans are used for
delineation of the bladder on the CBCT-scans from the first 4 fractions. The adaptive plans
are generated from the union of the first 4 CBCT-bladders and the planning CT bladder
(medium size) and the volume contained in at least 2 out of the 5 bladder volumes (small
size). Details can be found in the reference list. From the 6'Th fraction the treatment is
performed using the most appropriate size of treatment plan. CTCAE is repeated every other
week during radiotherapy and 2 weeks, 3, 6, 12 and 24 month after radiotherapy.

Inclusion Criteria:

- Histologically proven bladder cancer

- Age over 18 years

- Urothelial or planocellular carcinoma

- Stage T2 T4A

- Stage N0M0

- Suitable for radiotherapy

- ECOG/WHO performance status 0-2

Exclusion Criteria:

- Suspected or confirmed distant metastases

- Previous surgery in the small pelvis

- Inflammatory bowel disease

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Gastro- Intestinal toxicity

Outcome Description:

Grade 2 or more GI toxicity using CTCAE 4.0 baseline, every 2'nd week during RT, 2 weeks, 3, 12 and 24 month after RT

Outcome Time Frame:

Up to 2 years after ART

Safety Issue:


Principal Investigator

Morten Høyer, MD, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aarhus University Hospital


Denmark: Ethics Committee

Study ID:




Start Date:

October 2012

Completion Date:

April 2016

Related Keywords:

  • Adverse Effects for Adaptive RT of Bladder Cancer
  • Adaptive radiotherapy
  • Bladder cancer
  • Urinary Bladder Neoplasms