NCT01762527

Brief Summary

This protocol describes a Phase 2 clinical trial of online adaptive Radiotherapy, using a library of 3 dose plans corresponding to Small, Medium and Large size bladder. The procedure includes 'Common Toxicity Criteria for Adverse Effects'(CTCAE) for registration of adverse effects (baseline, every 2'nd week during RT, 2 weeks, 3, 6, 12 and 24 month after RT) as well as cineMR for intra-fractional motion (baseline and every week during RT). Patients receive standard non-adaptive RT in the first week. Delineations of the bladder on the Cone-Beam scans (CBCT) from first week of treatment are used for planning the Small and Medium size bladder plans. Large size plan are the standard non-adaptive treatment plan used for the first week of treatment. A margin of 5 mm for intra fractional movement is used.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2016

Completed
Last Updated

May 6, 2021

Status Verified

December 1, 2015

Enrollment Period

4.1 years

First QC Date

January 3, 2013

Last Update Submit

May 4, 2021

Conditions

Adverse Effects for Adaptive RT of Bladder Cancer

Keywords

Adaptive radiotherapyBladder cancer

Outcome Measures

Primary Outcomes (1)

  • Gastro- Intestinal toxicity

    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

    Up to 2 years after ART

Secondary Outcomes (3)

  • Intra-fractional changes of bladder shape and size

    spring 2013

  • Difference in accumulated dose to normal tissue

    autum 2014

  • 1 or 2 years disease free survival

    2015

Study Arms (1)

ART

EXPERIMENTAL

Online adaptive radiotherapy

Radiation: Adaptive Radiotherapy

Interventions

Adaptive RadiotherapyRADIATION

CTCAE scoring baseline, every 2'nd week during RT, 2 weeks, 3, 12 and 24 month after RT cineMR (time resolved MR) baseline and weekly during RT for intra fractional motion

Also known as: Online Adaptive RT using plan selection
ART

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Suspected or confirmed distant metastases
  • Previous surgery in the small pelvis
  • Inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Oncology, Aarhus University Hospital

Aarhus, 8000 C, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (4)

  • Vestergaard A, Sondergaard J, Petersen JB, Hoyer M, Muren LP. A comparison of three different adaptive strategies in image-guided radiotherapy of bladder cancer. Acta Oncol. 2010 Oct;49(7):1069-76. doi: 10.3109/0284186X.2010.501813.

    PMID: 20831498BACKGROUND

  • Vestergaard A, Hafeez S, Muren LP, Nill S, Hoyer M, Hansen VN, Gronborg C, Pedersen EM, Petersen JB, Huddart R, Oelfke U. The potential of MRI-guided online adaptive re-optimisation in radiotherapy of urinary bladder cancer. Radiother Oncol. 2016 Jan;118(1):154-9. doi: 10.1016/j.radonc.2015.11.003. Epub 2015 Nov 26.

    PMID: 26631646BACKGROUND

  • Vestergaard A, Muren LP, Lindberg H, Jakobsen KL, Petersen JB, Elstrom UV, Agerbaek M, Hoyer M. Normal tissue sparing in a phase II trial on daily adaptive plan selection in radiotherapy for urinary bladder cancer. Acta Oncol. 2014 Aug;53(8):997-1004. doi: 10.3109/0284186X.2014.928419. Epub 2014 Jun 24.

    PMID: 24957559RESULT

  • Gronborg C, Vestergaard A, Hoyer M, Sohn M, Pedersen EM, Petersen JB, Agerbaek M, Muren LP. Intra-fractional bladder motion and margins in adaptive radiotherapy for urinary bladder cancer. Acta Oncol. 2015;54(9):1461-6. doi: 10.3109/0284186X.2015.1062138. Epub 2015 Aug 27.

    PMID: 26313410RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Morten Høyer, MD, Professor

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Daily adaptation of radiotherapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 7, 2013

Study Start

October 1, 2012

Primary Completion

October 30, 2016

Study Completion

October 30, 2016

Last Updated

May 6, 2021

Record last verified: 2015-12

Locations

DK(3)