- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01810757
Study of Weekly Radiotherapy for Bladder Cancer (HYBRID)
A Multicentre Randomised Phase II Study of HYpofractionated Bladder Radiotherapy With or Without Image Guided aDaptive Planning
Background Localised muscle invasive bladder cancer (MIBC) is life-threatening and can cause significant symptoms. Around 50% of patients with MIBC who are referred for radiotherapy are unfit for standard radical treatment (surgery or daily radiotherapy with chemotherapy), but would have a normal life expectancy if their cancer were adequately controlled. Retrospective studies suggest that radiotherapy which is given weekly using fewer fractions and higher doses (hypofractionated), may be an alternative where daily radiotherapy is not an option.
Radiotherapy treatment is planned based on information from a CT scan which shows the position and shape of the bladder. This plan needs to take into account the fact that the bladder's shape and position can change, depending on how full it is and because of where it is in relation to the bowel. A safety margin is therefore added around the bladder on the planned treatment, to reduce the risk of missing any of the bladder with the radiotherapy.
It is now possible to take scans of the bladder's position before each treatment and adjust the position of the treatment plan accordingly to ensure the bladder is fully covered by it. In this study we are also looking at whether it is possible to design a series of treatment plans with different size safety margins and then choose one that fits best for each particular day. This is called 'adaptive radiotherapy'. This technique may enable accurate treatment delivery using smaller safety margins and this might help to reduce side effects.
Aims
In patients with MIBC not suitable for cystectomy or daily radiotherapy we aim to assess:
- whether treatment using adaptive planning can be successfully delivered at multiple sites across the UK and results in acceptable levels of toxicity
- the local tumour control rate achieved by hypofractionated weekly radiotherapy
- the requirement to treat with adaptive planning.
How results will be used Results will provide robust evidence for use of hypofractionated radiotherapy and assess whether this is a plausible and worthwhile treatment in this patient population. The randomised element of the trial will support the implementation of image-guided adaptive radiotherapy for bladder cancer in the UK. HYBRID will provide evidence on the benefits or otherwise of this methodology and inform the development of further trials in this and other patient groups.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Cambridge, Det Forenede Kongerige
- Addenbrooke's Hospital
-
Cardiff, Det Forenede Kongerige
- Velindre Cancer Centre
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Ipswich, Det Forenede Kongerige
- Ipswich Hospital
-
Leeds, Det Forenede Kongerige
- St James's University Hospital
-
London, Det Forenede Kongerige
- University College London
-
London, Det Forenede Kongerige
- Royal Marsden NHSFT
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London, Det Forenede Kongerige
- Guy's & St Thomas's Hospital
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Norwich, Det Forenede Kongerige
- Norfolk & Norwich University Hospitals NHS Foundation Trust
-
Preston, Det Forenede Kongerige
- Royal Preston Hospital
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Romford, Det Forenede Kongerige
- Queens Hospital
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Wirral, Det Forenede Kongerige
- Clatterbridge Cancer Centre
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Written informed consent
- Age ≥18 years
- Histologically confirmed invasive bladder carcinoma (T2-T4a N0 M0; any histological sub-type)
- Unsuitable for radical cystectomy or daily fractionated radiotherapy for any reason (including performance status, co-morbidity, patient refusal)
- Expected survival >6 months
- WHO performance status 0-3
- Willing to undergo post treatment cystoscopy
Exclusion Criteria:
- Nodal or metastatic disease
- Concurrent malignancy
- Previous pelvic radiotherapy
- Urinary catheter in-situ
- Any other contra-indication to radiotherapy (e.g. inflammatory bowel disease)
- Unable to attend for post treatment follow up
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Standard planning
Standard planning radiotherapy
|
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
|
Eksperimentel: Adaptive planning
Adaptive planning radiotherapy
|
36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Proportion of patients experiencing severe acute non-genitourinary side effects following radiotherapy.
Tidsramme: 12 weeks from start of radiotherapy
|
Acute CTC non-genitourinary toxicity grade 3 or higher.
|
12 weeks from start of radiotherapy
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Local control
Tidsramme: 3 months
|
Presence of cancer in the bladder 3 months after treatment
|
3 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Robert Huddart, Institute of Cancer Research/RMNHSFT
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CCR3973
- CRUK/12/055 (Andet bevillings-/finansieringsnummer: CRUK)
- ICR-CTSU/2013/10039 (Anden identifikator: ICR-CTSU Protocol Number)
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