Bladder CancerPhase 1NCT01124682
3-Dimensional Conformal Radiation Therapy in Treating Patients With Bladder Cancer Who Have Undergone Transurethral Resection of the Bladder
A Phase 1 study testing diagnostic cystoscopy, diffusion-weighted magnetic resonance imaging and implanted fiducial-based imaging in people with Bladder Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- diagnostic cystoscopy, diffusion-weighted magnetic resonance imaging and implanted fiducial-based imaging
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2009to Apr 2016
- Phase
- Phase 1
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive bladder carcinoma, including the following cellular types:
- Adenocarcinoma
- Transitional cell carcinoma
- Squamous cell carcinoma
- Clinical stage G1-3, pT2a-4 disease
- Localized disease
- No bone or visceral metastases
- No lymph node metastases
- Has undergone maximal transurethral resection of the bladder tumor and planning to receive radical radiotherapy
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Hemoglobin > 10 g/dL
- WBC > 3,000/mm^3
- Platelet count > 150,000/mm^3
- Creatinine < 120 μmol/L
- Bilirubin < 1.5 times upper limit normal (ULN)
- AST < 1.5 times ULN
- Alkaline phosphatase < 1.5 times ULN
- Not pregnant
- No inflammatory bowel disease or other significant small bowel disease
- Physically fit for radical radiotherapy
- No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- No other malignancy within the past 2 years except adequately treated basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix uteri
- Prior superficial transitional cell carcinoma of the bladder allowed
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior pelvic surgery
- No bilateral hip replacements compromising accurate radiotherapy planning
- No prior radiotherapy to the pelvis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Contact Person, 44-20-8661-3457, robert.huddart@icr.ac.uk
About this study
Official title: Image Guided Dose Escalated Adaptive Bladder Radiotherapy
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of 3-dimensional conformal radiation therapy in treating patients with bladder cancer who have undergone transurethral resection of the bladder.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose of external-beam radiotherapy delivered as a tumor boost in patients who have undergone prior transurethral bladder resection for muscle-invasive carcinoma of the bladder.
Secondary
- To document progression-free survival and overall survival of these patients.
- To evaluate patterns of recurrence and bladder preservation rates following dose-escalated radiotherapy in these patients.
- To determine the impact of acute and late toxicity on quality of life in these patients.
- To assess the use of gold seeds for tumor boost delineation in these patients.
- To evaluate the use of virtual cystoscopy tumor localization in these patients.
- To assess coverage of the phase II radiotherapy boost volume on the daily cone-beam images.
- To assess coverage of the phase III radiotherapy volume on cone-beam images with selected adaptive strategy.
- To evaluate the use of diffusion-weighted MRI (dwMRI) scans in assessing response to radiotherapy.
OUTLINE: This is a dose-escalation study.
Patients undergo a rigid cystoscopy and gold-seed insertion, if clinically appropriate. Approximately 3-5 seeds are inserted into the bladder wall to demarcate the maximum extent of visible tumor or tumor bed via a customized introducer. All patients undergo 3-dimensional conformal radiotherapy once daily, 5 days per week during weeks 1 and 4-7 and once daily, 4-6 days per week during weeks 2 and 3, using a combination of image-guided radiotherapy techniques and a partial bladder radiotherapy boost.
Patients complete quality-of-life questionnaire QOL-30 at baseline, 1 and 3 months, and then annually after completion of study treatment.
After completion of study treatment, patients are followed up at 4, 8, and 12 weeks, every 6 months for 3 years, and then annually for 2 years.
- Conditions
- Bladder Cancer
- Being tested
- diagnostic cystoscopy, diffusion-weighted magnetic resonance imaging, implanted fiducial-based imaging, quality-of-life assessment, 3-dimensional conformal radiation therapy
- Keywords
- adenocarcinoma of the bladder, squamous cell carcinoma of the bladder, transitional cell carcinoma of the bladder, recurrent bladder cancer, stage II bladder cancer, stage III bladder cancer, stage IV 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.
diagnostic cystoscopyProcedure or surgery
diffusion-weighted magnetic resonance imagingProcedure or surgery
implanted fiducial-based imagingProcedure or surgery
quality-of-life assessmentProcedure or surgery
3-dimensional conformal radiation therapyRadiation
image-guided radiation therapyRadiation
selective external radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum-tolerated dose
Secondary outcomes (8)
Progression-free survival
Overall survival
Bladder preservation rates
Acute and late toxicity and safety profile
Quality of life
Tumor boost volumes delineated with and without gold seeds
Dose-volume histogram analysis of PTV2 and PTV3 coverage
Change in diffusion coefficient between pre- and post-radiotherapy dwMRI scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startMay 2009
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Investigators
- Robert A. Huddart, MD, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124682
- Sponsor's protocol ID
- CDR0000671670
- Other IDs
- ICR-IDEAL, EU-21035, CCR-3217, MREC-09/H0801/40
- Status last verified
- Feb 2011
- First submitted
- 14 May 2010
- Last updated
- 26 Aug 2013
- Results posted
- No
Publications
Hafeez S, Warren-Oseni K, Jones K, Mohammed K, El-Ghzal A, Dearnaley D, Harris V, Khan A, Kumar P, Lalondrelle S, McDonald F, Tan M, Thomas K, Thompson A, McNair HA, Hansen VN, Huddart RA. Bladder Tumor-Focused Adaptive Radiation Therapy: Clinical Outcomes of a Phase I Dose Escalation Study. Int J Radiat Oncol Biol Phys. 2025 Jan 1;121(1):165-175. doi: 10.1016/j.ijrobp.2024.07.2317. Epub 2024 Jul 26.
PubMed 39069239
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Guided Dose Escalated Adaptive Bladder Radiotherapy
- ClinicalTrials.gov ID
- NCT01124682
- Acronym / sponsor ID
- CDR0000671670
- Conditions
- Bladder Cancer
- Keywords
- adenocarcinoma of the bladder, squamous cell carcinoma of the bladder, transitional cell carcinoma of the bladder, recurrent bladder cancer, stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Apr 2016 (estimated)
- First posted
- 17 May 2010 (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.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of 3-dimensional conformal radiation therapy in treating patients with bladder cancer who have undergone transurethral resection of the bladder.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose of external-beam radiotherapy delivered as a tumor boost in patients who have undergone prior transurethral bladder resection for muscle-invasive carcinoma of the bladder.
Secondary
- To document progression-free survival and overall survival of these patients.
- To evaluate patterns of recurrence and bladder preservation rates following dose-escalated radiotherapy in these patients.
- To determine the impact of acute and late toxicity on quality of life in these patients.
- To assess the use of gold seeds for tumor boost delineation in these patients.
- To evaluate the use of virtual cystoscopy tumor localization in these patients.
- To assess coverage of the phase II radiotherapy boost volume on the daily cone-beam images.
- To assess coverage of the phase III radiotherapy volume on cone-beam images with selected adaptive strategy.
- To evaluate the use of diffusion-weighted MRI (dwMRI) scans in assessing response to radiotherapy.
OUTLINE: This is a dose-escalation study.
Patients undergo a rigid cystoscopy and gold-seed insertion, if clinically appropriate. Approximately 3-5 seeds are inserted into the bladder wall to demarcate the maximum extent of visible tumor or tumor bed via a customized introducer. All patients undergo 3-dimensional conformal radiotherapy once daily, 5 days per week during weeks 1 and 4-7 and once daily, 4-6 days per week during weeks 2 and 3, using a combination of image-guided radiotherapy techniques and a partial bladder radiotherapy boost.
Patients complete quality-of-life questionnaire QOL-30 at baseline, 1 and 3 months, and then annually after completion of study treatment.
After completion of study treatment, patients are followed up at 4, 8, and 12 weeks, every 6 months for 3 years, and then annually for 2 years.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| diagnostic cystoscopy | Procedure or surgery | – |
| diffusion-weighted magnetic resonance imaging | Procedure or surgery | – |
| implanted fiducial-based imaging | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
| 3-dimensional conformal radiation therapy | Radiation | – |
| image-guided radiation therapy | Radiation | – |
| selective external radiation therapy | Radiation | – |
Primary outcome
Maximum-tolerated dose
8 secondary outcomes
Progression-free survival
Overall survival
Bladder preservation rates
Acute and late toxicity and safety profile
Quality of life
Tumor boost volumes delineated with and without gold seeds
Dose-volume histogram analysis of PTV2 and PTV3 coverage
Change in diffusion coefficient between pre- and post-radiotherapy dwMRI scans
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Derived from this study: PubMed 39069239Hafeez S, Warren-Oseni K, Jones K, Mohammed K, El-Ghzal A, Dearnaley D, Harris V, Khan A, Kumar P, Lalondrelle S, McDonald F, Tan M, Thomas K, Thompson A, McNair HA, Hansen VN, Huddart RA. Bladder Tumor-Focused Adaptive Radiation Therapy: Clinical Outcomes of a Phase I Dose Escalation Study. Int J Radiat Oncol Biol Phys. 2025 Jan 1;121(1):165-175. doi: 10.1016/j.ijrobp.2024.07.2317. Epub 2024 Jul 26.
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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.
Robert A. Huddart, MD principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing diagnostic cystoscopy, diffusion-weighted magnetic resonance imaging and implanted fiducial-based imaging in people with Bladder Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum-tolerated dose. 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 NCT01124682, which also lists 1 linked publication.
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 26 Aug 2013; AzTrials last refreshed its copy on 31 Oct 2026.