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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Radiation Therapy
Sponsored by
Trans Tasman Radiation Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Bladder, Radiotherapy, Online, Adaptive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Prince Alfred Hospital
  • Calvary Mater Newcastle
  • Westmead Hospital
  • Mater Hospital
  • Townsville Hospital
  • Princess Alexandra Hospital
  • Royal Hobart Hospital
  • Peter MacCallum Cancer Centre - Box Hill
  • Peter MacCallum Cancer Centre - Morrabbin
  • Alfred Hospital
  • Christchurch Hospital
  • Waikato Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Radiation Therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
Late normal tissue effects
Patients will be assessed at 3 monts post radiotherapy, then every 3 months until 2 years post radiotherapy.
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.

Full Information

First Posted
May 27, 2010
Last Updated
January 22, 2017
Sponsor
Trans Tasman Radiation Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT01142102
Brief Title
Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer
Acronym
BOLART
Official Title
A Multicentre Feasibility Study of Online Adaptive Image Guided Radiotherapy for Muscle Invasive Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trans Tasman Radiation Oncology Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Bladder, Radiotherapy, Online, Adaptive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Radiation Therapy
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compliance with Online Adaptive Radiation Therapy process
Description
A patient is considered to be compliant if that patient completes treatment without experiencing a major protocol deviation
Time Frame
From the start date of radiotherapy to the last day of radiotherapy treatment (approxiamately 6 weeks and 2 days)
Secondary Outcome Measure Information:
Title
Pattern of failure and competing risks analysis
Description
Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.
Time Frame
From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
Title
Disease Free survival
Description
Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.
Time Frame
From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial
Title
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.
Description
Patients will be assesed at baseline, weekly durning radiotherapy, then at one month and three months post radiotherapy.
Time Frame
From start date of radiotherapy and within 3 months of completion of radiation treatment
Title
Quality of Life
Description
Patients will be assessed at baseline, on the last day of radiotherapy, at one month post radiotherapy, then at 18 months follow up.
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.
Title
Late normal tissue effects
Description
Patients will be assessed at 3 monts post radiotherapy, then every 3 months until 2 years post radiotherapy.
Time Frame
Between 3 months and 3 years after the completion of radiation treatment
Title
Time to Local Bladder Failure
Description
Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy.
Time Frame
From date of enrolment to date of local bladder failure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Farshad Foroudi
Organizational Affiliation
Peter MacCallum Cancer Centre, Australia
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Mater Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Townsville Hospital
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Peter MacCallum Cancer Centre - Box Hill
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Peter MacCallum Cancer Centre - Morrabbin
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Alfred Hospital
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
4710
Country
New Zealand
Facility Name
Waikato Hospital
City
Waikato
ZIP/Postal Code
3240
Country
New Zealand

12. IPD Sharing Statement

Links:
URL
http://www.trog.com.au
Description
Click here for more information about this study on the TROG official website

Learn more about this trial

Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer

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