Adaptive Predictive Planning for hypofractioned bLadder radiotherapY
| ISRCTN | ISRCTN80815524 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80815524 |
| ClinicalTrials.gov (NCT) | NCT01000129 |
| Protocol serial number | CCR 3122 |
| Sponsor | Institute of Cancer Research (UK) |
| Funders | Cancer Research UK (CRUK) (UK) (ref: C46/A3970), Francis Wain Jewellers Ltd (UK) - charitable donation |
- 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
Scientific
Institute of Cancer Research
15 Cotswolds Road
Belmont
SM2 5PT
United Kingdom
| Phone | +44 (0)20 8661 352 |
|---|---|
| Robert.Huddart@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective non-blinded non-randomised phase II study |
| Secondary study design | Non randomised study |
| Study type | Participant 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(s) |
Appropriate identification and correction of fractions requiring adaptive planning, assessed at the end of treatment. |
| Key secondary outcome measure(s) |
1. Proportion of fractions requiring adaptive planning, assessed at end of treatment |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Institute of Cancer Research
Belmont
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes |
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.
