Adverse Effects for Adaptive RT of Bladder Cancerplan selectionNCT01762527
Adaptive Radiotherapy Using Plan Selection for Bladder Cancer
A study testing Adaptive Radiotherapy in people with Adverse Effects for Adaptive RT of Bladder Cancer, run by University of Aarhus at 3 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Effects for Adaptive RT of Bladder Cancer
- What is being tested?
- Adaptive Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesDenmark
- Study dates
- Oct 2012to 30 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Suspected or confirmed distant metastases
- Previous surgery in the small pelvis
- Inflammatory bowel disease
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Department of Oncology, Aarhus University Hospital
Aarhus, 8000 C
Herlev Hospital
Herlev, 2730
Odense University Hospital
Odense, 5000
About this study
Official title: Adaptive Radiotherapy Using Plan Selection for Bladder Cancer: A Phase II Trial
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.
Read the detailed description
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.
- Being tested
- Adaptive Radiotherapy
- Keywords
- Adaptive radiotherapy, Bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive RadiotherapyRadiation
Also called Online Adaptive RT using plan selection
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
| Study group | Role | What they receive |
|---|---|---|
| ART | Experimental | Online adaptive radiotherapy Receives: Radiation: Adaptive Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 years after ART
Secondary outcomes (3)
Intra-fractional changes of bladder shape and size
CineMR (time resolved MR) is performed pre-treatment and weekly during RT for the first 10 patients
Measured: spring 2013
Difference in accumulated dose to normal tissue
The gain of normal tissue sparring will be calculated using dose accumulation
Measured: autum 2014
1 or 2 years disease free survival
1 or 2 years disease free survival will be calculated
Measured: 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startOct 2012
- Primary completion30 Oct 2016
- Study completion30 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adverse Effects for Adaptive RT of Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Daily adaptation of radiotherapy
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Morten Høyer, MD, Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762527
- Sponsor's protocol ID
- AUH-KFE-1217
- Other IDs
- jr.nr. 1-16-02-283-12
- Acronym
- plan selection
- Status last verified
- Dec 2015
- First submitted
- 3 Jan 2013
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20831498Vestergaard 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.
PubMed 26631646Vestergaard 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.
PubMed 24957559Gronborg 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.
PubMed 26313410
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Radiotherapy Using Plan Selection for Bladder Cancer: A Phase II Trial
- ClinicalTrials.gov ID
- NCT01762527
- Acronym / sponsor ID
- plan selection / AUH-KFE-1217
- Keywords
- Adaptive radiotherapy, Bladder cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Odense University Hospital
- Study start
- Oct 2012 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Daily adaptation of radiotherapy
| Arm | Type | Receives |
|---|---|---|
| ART | Experimental | Radiation: Adaptive RadiotherapyOnline adaptive radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically proven bladder cancer
- Age over 18 years
- Urothelial or planocellular carcinoma
- Stage T2 T4A
- Stage N0M0
Key exclusion criteria (3 listed)
- Suspected or confirmed distant metastases
- Previous surgery in the small pelvis
- Inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive RadiotherapyAlso: Online Adaptive RT using plan selectionCTCAE 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 | Radiation | ART |
Primary outcome
Gastro- Intestinal toxicity
Time frame: Up to 2 years after ART
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
3 secondary outcomes
Intra-fractional changes of bladder shape and size
Time frame: spring 2013
Difference in accumulated dose to normal tissue
Time frame: autum 2014
1 or 2 years disease free survival
Time frame: 2015
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Background: PubMed 20831498Vestergaard 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.
- Background: PubMed 26631646Vestergaard 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.
- Results publication: PubMed 24957559Vestergaard 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.
- Results publication: PubMed 26313410Gronborg 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Høyer, MD, Professor principal investigator
Aarhus University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Radiotherapy in people with Adverse Effects for Adaptive RT of Bladder Cancer, run by University of Aarhus at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastro- Intestinal toxicity (time frame: Up to 2 years after ART). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01762527, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.