Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer

Trans Tasman Radiation Oncology Group (TROG) 10.01 - A multi-centre feasibility study of online adaptive image guided radiotherapy for muscle invasive bladder cancer

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000711011

Acronym

BOLART

Enrollment

Registered

2010-08-26

Start date

2010-08-16

Completion date

2012-12-01

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The principal objective of the trial is to test the hypothesis that Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer is feasible across multiple Radiation Oncology departments.

Interventions

Radiation Therapy A radical dose of radiotherapy (RT) to be delivered to the entire bladder volume: 64Gy in 32 fractions over 6 weeks and 2 days. Conventional plan is used to deliver treatment for fractions 1-7 using a standard planning approach and a Clinical Target Volume (CTV) to Planning Target Volume (PTV) margin of 1.5cm. Adaptive plan is used to deliver treatment for fractions 8-32 using the same standard techniques as for fractions 1-7 but using one of the three specific CTV's, namely: small, average and large. In all these cases the CTV to PTV margin is 0.7cm. Image guidence using a treatment unit based verification Computed Tomography (CT) unit (cone beam CT or CT on rails) based on soft tissue delinieation is used to position the traetment fields and select the plan to best cover the CTV.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Aged 18 years or older 2. Has provided written Informed Consent for participation in this trial 3. Histologically confirmed muscle invasive bladder cancer. 4. Transitional cell, squamous cell, adenocarcinoma or mixed histology. Stage T2-4 N0 M0. 5. An Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. 6. Life expectancy greater than 6 months. 7. Considered suitable for radical radiotherapy. 8. Participants capable of childbearing are using adequate contraception. 9. Radiotherapy must be able to be commenced within 12 weeks of surgery. 10. Available for follow up.

Exclusion criteria

1. Women who are pregnant or lactating. 2. Previous pelvic radiotherapy 3. Previous cystectomy 4. A small contracted bladder 5. Unilateral or bilateral hip replacement 6. Small cell histology 7.Clinical or radiological evidence of nodal or distant metastases 8. Presence of indwelling urinary catheter

Outcome results