Plain English Summary
http://www.cancerhelp.org.uk/trials/a-study-radiotherapy-bladder-cancer-APPLY
Trial website
Contact information
Type
Scientific
Primary contact
Dr Robert Huddart
ORCID ID
Contact details
Institute of Cancer Research
15 Cotswolds Road
Belmont
SM2 5PT
United Kingdom
+44 (0)20 8661 352
Robert.Huddart@icr.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01000129
Protocol/serial number
CCR 3122
Study information
Scientific title
Adaptive predictive planning for hypofractioned bladder radiotherapy: a prospective phase II study
Acronym
APPLY
Study hypothesis
There is a continued need for adaptive planning in patients receiving radiotherapy for bladder cancer which can be incorporated into the treatment pathway using an adaptive-predictive organ localisation (A-POLO) methodology.
On 01/03/2011 the overall trial end date was changed from 27/01/2011 to 31/12/2011.
Ethics approval
Royal Marsden Research Ethics Committee, 18/12/2008, ref: 08/H0801/137
Study design
Prospective non-blinded non-randomised phase II study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Muscle invasive bladder cancer
Intervention
A prospective phase II study clinically implementing adaptive planning in radiotherapy for bladder cancer. All eligible patients will be treated with new clinical protocol.
All patients will undergo computed tomography (CT) planning scans at 0, 30 minutes post-void (CT1, CT2). The clinical target volume (CTV) will be contoured on each scan, defined as the whole bladder plus any area of extravesical spread (CTV1, CTV2). A series of three 3-dimensional conformal plans will be generated for each patient according to the following CTV expansion margins:
Plan 1 (standard): planning target volume 2 (PTV2) = CTV1 + 0.5 cm laterally and inferiorly + 1 cm posteriorly + 1.5 cm superiorly and anteriorly
Plan 2 (small): PTV1 = CTV1 + 0.5 cm isotropically
Plan 3 (large): PTV3 = CTV2 + 0.5 cm laterally and inferiorly + 1 cm posteriorly + 1.5 cm superiorly and anteriorly
If the difference in volume between CTV1 and CTV2 is less than 50 cc, PTV3 = CTV1 + 0.75 cm laterally and inferiorly + 1.2 cm posteriorly + 2.5 cm superiorly and inferiorly.
Patients will receive up to six fractions of radiotherapy delivered weekly. Prior to each fraction a cone beam CT scan will be performed followed by online set-up correction. Each PTV contour will be assessed to determine the PTV providing the best fit. The most appropriate contour is that which encompasses the bladder as seen on CBCT + 2 - 3 mm superiorly. The plan selected will be confirmed by a second observer. Treatment is then delivered using the corresponding plan. A post-treatment cone beam image will be taken to ensure that intrafraction motion is accounted for.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
Appropriate identification and correction of fractions requiring adaptive planning, assessed at the end of treatment.
Secondary outcome measures
1. Proportion of fractions requiring adaptive planning, assessed at end of treatment
2. Dose-volume histogram (DVH) analysis of CTV coverage using anisotropic margins, assessed at end of treatment
3. Time to local disease progression, measured at 2 years
4. Overall survival, measured at 2 years
Overall trial start date
27/01/2009
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged greater than 18 years, either sex
2. Histologically confirmed invasive carcinoma of the bladder
3. Patient planned to receive hypofractionated radiotherapy to the bladder
4. No previous pelvic radiotherapy
5. Written informed consent given according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (ICH/GCP) and national/local regulations
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
32
Participant exclusion criteria
Urinary catheter in-situ
Recruitment start date
27/01/2009
Recruitment end date
31/12/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Cancer Research
Belmont
SM2 5PT
United Kingdom
Sponsor information
Organisation
Institute of Cancer Research (UK)
Sponsor details
123 Old Brompton Road
London
SW7 3RP
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C46/A3970)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Funder name
Francis Wain Jewellers Ltd (UK) - charitable donation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in https://www.ncbi.nlm.nih.gov/pubmed/20472358