Bladder NeoplasmsPhase 1/2NCT00963404
Image-Guided Tumorboost of Bladder Cancer
A Phase 1/2 study testing Radiation boost in people with Bladder Neoplasms, run by University of Aarhus at 4 sites in Denmark.
Trial summary
The purpose of the study is to increase the radiation dose (Boost) to the bladder tumor. The bladder cancer patients included in the study will undergo tumor demarcation. The bladder demarcations will then be the target for an image-guided boost delivered precisely to the expected tumor site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Neoplasms
- What is being tested?
- Radiation boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesDenmark
- Study dates
- Aug 2009to Jan 2017
- Phase
- Phase 1/2
- 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
- Muscle invasive bladder cancer (transitional carcinoma)
- Unifocal
- TNM stage T2a-4a, N0-1, M0
- unfit for radical cystectomy
Who cannot join
- Hyperthyroidism
- Multinodular goiter
- Pregnancy
- Breast feeding
- WHO preformance status more than 2
- Iodine allergy
- MRI or CT contrast media allergy
- Bi-lateral hip-prosthesis
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
The department of Oncology, Aarhus University Hospital
Aarhus, Dk-8000
The department of Oncology, Rigshospitalet
Copenhagen, Dk-2100
The department of Oncology, Herlev University Hospital
Herlev, Dk-2730
The department of Oncology, Odense University Hospital
Odense, Dk-5000
About this study
Official title: Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study
The purpose of the study is to increase the radiation dose (Boost) to the bladder tumor. The bladder cancer patients included in the study will undergo tumor demarcation. The bladder demarcations will then be the target for an image-guided boost delivered precisely to the expected tumor site.
- Conditions
- Bladder Neoplasms
- Being tested
- Radiation boost
- Keywords
- Image-guided Radiotherapy, Fiducial marker, Adverse effects
- 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.
Radiation boostRadiation
Radiation boost of the bladder-tumor: 10 Gy/5 fractions, 2 Gy per fraction.
| Study group | Role | What they receive |
|---|---|---|
| Tumor-boost | Experimental | Image-guided tumorboost of the bladder cancer. Receives: Radiation: Radiation boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor control
Measured: One year
Secondary outcomes (1)
Acute and late adverse effects of the radiotherapy treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Jimmi Sondergaard, Principal investigator, The department of Oncology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963404
- Sponsor's protocol ID
- CIRRO IP 070109 DaBlaCa-1
- Other IDs
- M-20080210
- Status last verified
- Jan 2018
- First submitted
- 20 Aug 2009
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study
- ClinicalTrials.gov ID
- NCT00963404
- Acronym / sponsor ID
- CIRRO IP 070109 DaBlaCa-1
- Conditions
- Bladder Neoplasms
- Keywords
- Image-guided Radiotherapy, Fiducial marker, Adverse effects
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Aug 2009
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 21 Aug 2009 (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.
The purpose of the study is to increase the radiation dose (Boost) to the bladder tumor. The bladder cancer patients included in the study will undergo tumor demarcation. The bladder demarcations will then be the target for an image-guided boost delivered precisely to the expected tumor site.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor-boost | Experimental | Radiation: Radiation boostImage-guided tumorboost of the bladder cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Muscle invasive bladder cancer (transitional carcinoma)
- Unifocal
- TNM stage T2a-4a, N0-1, M0
- unfit for radical cystectomy
Key exclusion criteria (8 listed)
- Hyperthyroidism
- Multinodular goiter
- Pregnancy
- Breast feeding
- WHO preformance status more than 2
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 |
|---|---|---|
| Radiation boostRadiation boost of the bladder-tumor: 10 Gy/5 fractions, 2 Gy per fraction. | Radiation | Tumor-boost |
Primary outcome
Local tumor control
Time frame: One year
1 secondary outcome
Acute and late adverse effects of the radiotherapy treatment
Time frame: 3 years
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 3 May 2018.
- Related InfoLink provided by the sponsor.
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A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
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A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
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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.
Jimmi Sondergaard principal investigator
The department of Oncology, Aarhus University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radiation boost in people with Bladder Neoplasms, run by University of Aarhus at 4 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 4 inclusion and 8 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 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Local tumor control (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2018.