Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer

Bladder Cancer Clinical Trial

— BOLART  

Official title:

A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142102
• Other study ID #: TROG 10.01
• Secondary ID: ACTRN12610000711
• Status: Completed
• Phase: N/A
• First received: May 27, 2010
• Last updated: January 22, 2017
• Start date: October 2010
• Est. completion date: June 2015

Study information

• Verified date: January 2017
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a single-arm multicentre feasibility trial in which the primary aim is to determine the compliance rate of patients to online adaptive radiotherapy for muscle invasive bladder cancer over multiple Australian and New Zealand centres. The compliance rate is defined as the proportion of patients successfully completing treatment without a major protocol deviation.

Subject to the accrual being at least 40 patients in the first 2 years, accrual will continue until a total of 50 patients have been accrued. If this accrual target is not met, then consideration will be given to stopping the trial early due to poor accrual. Each patient will be followed-up until 2 years after the last patient's date of accrual. Assessments for toxicity and recurrence or progression will take place at four weeks after completion of treatment, then three monthly from the end of treatment for the first 12 months and then 6 monthly thereafter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or older

• Has provided written Informed Consent for participation in this trial

• Histologically confirmed muscle invasive bladder cancer.

• Transitional cell, squamous cell, adenocarcinoma or mixed histology. Stage T2-4 N0 M0.

• An ECOG performance status score of 2 or less (see appendices).

• Life expectancy greater than 6 months.

• Considered suitable for radical radiotherapy.

• Participants capable of childbearing are using adequate contraception.

• Radiotherapy must be able to be commenced within 12 weeks of surgery.

• Available for follow up.

Exclusion Criteria:

• Women who are pregnant or lactating.

• Previous pelvic radiotherapy

• Previous cystectomy

• A small contracted bladder

• Unilateral or bilateral hip replacement

• Small cell histology

• Clinical or radiological evidence of nodal or distant metastases

• Presence of indwelling urinary catheter

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Radiation:
• Radiation Therapy
A radical dose of radiotherapy to be delivered to the entire bladder volume: 64Gy in 32 fractions over 6 weeks and 2 treatment days. Conventional plan is used to deliver treatment for fractions 1 to 7 using a standard planning approach and a CTV to PTV margin of 1.5cm. Adaptive plan is used to deliver treatment for fractions 8 through 32 using the same standard techniques as for fractions 1 to 7 but using one of three specific CTV volumes,namely: small, average or large. In all these cases the CTV to PTV margin is 0.7cm. Image guidance using a treatment unit based verification CT unit (Cone Beam CT or CT on Rails)based on soft tissue delineation is used to position the treatment fields and select the plan to best cover the CTV.

Locations

Country	Name	City	State
Australia	Mater Hospital	Brisbane	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Townsville Hospital	Douglas	Queensland
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Peter MacCallum Cancer Centre - Box Hill	Melbourne	Victoria
Australia	Peter MacCallum Cancer Centre - Morrabbin	Melbourne	Victoria
Australia	Calvary Mater Newcastle	Newcastle	New South Wales
Australia	Alfred Hospital	Prahran	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Waikato Hospital	Waikato

Sponsors (1)

Lead Sponsor	Collaborator
Trans-Tasman Radiation Oncology Group (TROG)

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with Online Adaptive Radiation Therapy process	A patient is considered to be compliant if that patient completes treatment without experiencing a major protocol deviation	From the start date of radiotherapy to the last day of radiotherapy treatment (approxiamately 6 weeks and 2 days)
Secondary	Pattern of failure and competing risks analysis	Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.	From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
Secondary	Disease Free survival	Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.	From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
Secondary	Acute Toxicity of >/= grade 3 (NCI CTCAE version 4.0) of gastointestinal, diarrhoea, nausea, vomiting, colitis, proctitis, renal/genitourinary, cyctitis non-infective, haematuria, uinary frequency, urinary urgency and urinary retension.	Patients will be assesed at baseline, weekly durning radiotherapy, then at one month and three months post radiotherapy.	From start date of radiotherapy and within 3 months of completion of radiation treatment
Secondary	Quality of Life	Patients will be assessed at baseline, on the last day of radiotherapy, at one month post radiotherapy, then at 18 months follow up.	Within 2 weeks prior to commencement of treatment, during the last week of treatment, 1 and 18 months after the completion of treatment.
Secondary	Late normal tissue effects	Patients will be assessed at 3 monts post radiotherapy, then every 3 months until 2 years post radiotherapy.	Between 3 months and 3 years after the completion of radiation treatment
Secondary	Time to Local Bladder Failure	Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.	From date of enrolment to date of local bladder failure

External Links

•   Click here for more information about this study on the TROG official website