Adaptive Predictive Planning for hypofractioned bLadder radiotherapY

ISRCTN	ISRCTN80815524
DOI	https://doi.org/10.1186/ISRCTN80815524
ClinicalTrials.gov number	NCT01000129
Secondary identifying numbers	CCR 3122

Submission date: 27/01/2009
Registration date: 18/02/2009
Last edited: 27/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-study-radiotherapy-bladder-cancer-APPLY

Contact information

Dr Robert Huddart
Scientific

Institute of Cancer Research
15 Cotswolds Road
Belmont
SM2 5PT
United Kingdom

Phone	+44 (0)20 8661 352
Email	Robert.Huddart@icr.ac.uk

Study information

Study design	Prospective non-blinded non-randomised phase II study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Adaptive predictive planning for hypofractioned bladder radiotherapy: a prospective phase II study
Study acronym	APPLY
Study objectives	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(s)	Royal Marsden Research Ethics Committee, 18/12/2008, ref: 08/H0801/137
Health condition(s) or problem(s) studied	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
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 study start date	27/01/2009
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	32
Key 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
Key exclusion criteria	Urinary catheter in-situ
Date of first enrolment	27/01/2009
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Cancer Research

Belmont
SM2 5PT
United Kingdom

Sponsor information

Institute of Cancer Research (UK)
Research organisation

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Website	http://www.icr.ac.uk
"ROR"	https://ror.org/043jzw605

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C46/A3970)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Francis Wain Jewellers Ltd (UK) - charitable donation

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/03/2011		Yes	No

Editorial Notes

27/06/2019: Cancer Research UK lay results summary link added to Results (plain English).
22/09/2017: Internal review.
07/07/2017: Publication reference added.