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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT01142102
First received: May 27, 2010
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Bladder Cancer
Radiation: Radiation Therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    A patient is considered to be compliant if that patient completes treatment without experiencing a major protocol deviation


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.

  • 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 ] [ Designated as safety issue: No ]
    Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.

  • 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 ] [ Designated as safety issue: Yes ]
    Patients will be assesed at baseline, weekly durning radiotherapy, then at one month and three months post radiotherapy.

  • 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. ] [ Designated as safety issue: No ]
    Patients will be assessed at baseline, on the last day of radiotherapy, at one month post radiotherapy, then at 18 months follow up.

  • Late normal tissue effects [ Time Frame: Between 3 months and 3 years after the completion of radiation treatment ] [ Designated as safety issue: Yes ]
    Patients will be assessed at 3 monts post radiotherapy, then every 3 months until 2 years post radiotherapy.

  • Time to Local Bladder Failure [ Time Frame: From date of enrolment to date of local bladder failure ] [ Designated as safety issue: No ]
    Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.


Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: June 2015
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142102

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Mater Hospital
Brisbane, Queensland, Australia, 4101
Townsville Hospital
Douglas, Queensland, Australia, 4814
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Peter MacCallum Cancer Centre - Box Hill
Melbourne, Victoria, Australia, 3128
Peter MacCallum Cancer Centre - Morrabbin
Melbourne, Victoria, Australia, 3165
Alfred Hospital
Prahran, Victoria, Australia, 3181
New Zealand
Christchurch Hospital
Christchurch, New Zealand, 4710
Waikato Hospital
Waikato, New Zealand, 3240
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Investigators
Study Chair: Dr Farshad Foroudi Peter MacCallum Cancer Centre, Australia
  More Information

Additional Information:
No publications provided

Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT01142102     History of Changes
Other Study ID Numbers: TROG 10.01, ACTRN12610000711011
Study First Received: May 27, 2010
Last Updated: July 31, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Bladder
Radiotherapy
Online
Adaptive

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014