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A Multicentre Randomised Phase II Study of HYpofractionated Bladder Radiotherapy With or Without Image Guided aDaptive Planning


N/A
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

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Trial Information

A Multicentre Randomised Phase II Study of HYpofractionated Bladder Radiotherapy With or Without Image Guided aDaptive Planning


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients experiencing severe acute non-genitourinary side effects following radiotherapy.

Outcome Description:

Acute CTC non-genitourinary toxicity grade 3 or higher.

Outcome Time Frame:

12 weeks from start of radiotherapy

Safety Issue:

Yes

Principal Investigator

Robert Huddart

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Cancer Research/RMNHSFT

Authority:

United Kingdom: Research Ethics Committee

Study ID:

CCR3973

NCT ID:

NCT01810757

Start Date:

January 2014

Completion Date:

January 2025

Related Keywords:

  • Bladder Cancer
  • Urinary Bladder Neoplasms

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