Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer (BOLART)

January 22, 2017 updated by: Trans Tasman Radiation Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Newcastle, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Mater Hospital
      • Douglas, Queensland, Australia, 4814
        • Townsville Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3128
        • Peter MacCallum Cancer Centre - Box Hill
      • Melbourne, Victoria, Australia, 3165
        • Peter MacCallum Cancer Centre - Morrabbin
      • Prahran, Victoria, Australia, 3181
        • Alfred Hospital
  • New Zealand
      • Christchurch, New Zealand, 4710
        • Christchurch Hospital
      • Waikato, New Zealand, 3240
        • Waikato Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Radiation Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance with Online Adaptive Radiation Therapy process
Time Frame: From the start date of radiotherapy to the last day of radiotherapy treatment (approxiamately 6 weeks and 2 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of failure and competing risks analysis
Time Frame: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
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
Disease Free survival
Time Frame: From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
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
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.
Time Frame: From start date of radiotherapy and within 3 months of completion of radiation treatment
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
Quality of Life
Time Frame: Within 2 weeks prior to commencement of treatment, during the last week of treatment, 1 and 18 months after the completion of treatment.
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.
Late normal tissue effects
Time Frame: Between 3 months and 3 years after the completion of radiation treatment
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
Time to Local Bladder Failure
Time Frame: From date of enrolment to date of 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trans Tasman Radiation Oncology Group

Investigators

  • Study Chair: Dr Farshad Foroudi, Peter MacCallum Cancer Centre, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 27, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 22, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TROG 10.01
  • ACTRN12610000711011 (Registry Identifier: Austalian New Zealand Clinical Trial Regisrty)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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