Condition category
Cancer
Date applied
27/01/2009
Date assigned
18/02/2009
Last edited
10/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.icr.ac.uk

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes