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ANROTAT
The Assessment of New Radiation Oncology Technologies and Treatments (ANROTAT) TROG Research Project TRP11.A
Sponsor study identifier
observational
138
1 country
15
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2012
Actual (reported)Study Completion
June 2012
Actual (reported)The Trans Tasman Radiation Oncology Group (TROG) has been commissioned by the Department of Health and Ageing to undertake a project to assess new Radiation Oncology Technology and Treatments. This project is being undertaken in response to a recognised need for the Medicare Benefits Schedule to support appropriate new radiation oncology technologies and treatments as they become available, to ensure optimal patient care. The first phase of the project required TROG to develop a Generic Research Framework (the Framework) capable of collecting and generating information to substantiate the safety, clinical efficacy and cost effectiveness of new technologies and treatments. The second (and current) phase of the project requires that the Framework be piloted to assess the safety, clinical efficacy and cost effectiveness of Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT) in four tumour site specific regions: A. Post Prostatectomy(IMRT) B. Anal Cancer (IMRT) C. Nasopharynx (IMRT) D. Intermediate Risk Prostate Cancer (IGRT) The aims of the site specific components of the ANROTAT protocol are as follows: Protocol A. Develop an approach for applying the Framework to evaluate the safety, clinical efficacy and cost-effectiveness of IMRT compared to 3DCRT in patients with prostate cancer (PP). Protocol B. Develop an approach for applying the Framework to evaluate the safety, clinical efficacy and cost-effectiveness of IMRT compared to 3DCRT in AC. Protocol C. Develop an approach for applying the Framework to evaluate the safety, clinical efficacy and cost-effectiveness of IMRT compared to 3DCRT in NPC. Protocol D. Develop an approach for applying the Framework to evaluate the safety, clinical efficacy and cost-effectiveness of IGRT compared to non-IGRT in patients with intermediate risk prostate cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
June 8, 2011
Actual (reported)June 23, 2011
Actual (reported)May 2012
Actual (reported)June 2012
Actual (reported)Comparison of dosimetry between treatment plans prepared using IMRT/IGRT vs 3DCRT/Non IGRT as a surrogate for effectiveness and safety.
Measured By: 1. Tumour control estimated from surrogate physical dose endpoints with each of the new technologies as compared with standard therapy. 2. The likelihood of acute or long term damage to organ/tissue and resultant likelihood of impairment of function or QoL estimated from surrogate physical dose endpoints with each of the new technologies as compared with standard therapy.
6 Months
Obtain Data on the impact of disease and treatment on QoL
Measured by 1. QALYs gained, and cost-per-QALY gained 2. The likely cost increases or savings resulting from differences in acute or long term toxicity.
6 months
Compare the resource usage associated with the planning and delivery of the new technologies compared to the conventional standard approaches
* Prospective TROG 08.03 (RAVES) Participants * Prospective Participants (NOT participating in TROG 08.03 (RAVES)) * Retrospective TROG 08.03 (RAVES) Participants * Participating in dosimetric evaluation and toxicity/QoL study * Participating in dosimetric evaluation only
* Retrospective Patient Datasets * Prospective Participants (dosimetric evaluation and toxicity/QoL study)
* Retrospective Patient Datasets * Prospective Participants (dosimetric evaluation and toxicity/QoL study) * Post-Treatment Prospective Participants (toxicity/QoL and cost study)
Patients with prostate cancer \- A sample of 30 patients from at least 10 centres that are to be treated for intermediate risk prostate cancer will be enrolled. The sample will be selected to comprise at least 10 patients that will undergo non-IGRT, 10 that will undergo IGRT with fiducials and planar imaging, and 10 that will undergo IGRT with volumetric imaging.
This is a non-interventional study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Study Protocol A - IMRT Post Prostatectomy: Patients with prostate cancer (post prostatectomy) Study Protocol B - IMRT Anal Cancer: Patients with anal cancer Study Protocol C - IMRT Nasopharynx: Patients with nasopharynx cancer Study Protocol D - IGRT Intact Prostate: Patients with prostate cancer
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Liverpool Hospital
Liverpool, New South Wales, 1871, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, 2298, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Illawarra Cancer Care Centre
Wollongong, New South Wales, 2500, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Bryan Burmeister
Trans Tasman Radiation Oncology Group
138 participants (actual enrollment reported by the registry).
First Submitted
June 8, 2011
First Posted
June 23, 2011
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
1. The differences in time and resources required for preparation, planning, quality assurance (QA) checking and treatment for each of the new technologies as compared with standard therapy. 2. The likely cost increases or savings associated with differences in time and resources involved in the management of patients with each of the new technologies as compared with standard therapy.
6 months
Synthesise the data obtained for objectives 1-3 together with information from previous studies and expert opinion to estimate the safety, clinical efficacy and cost-effectiveness of new technologies compared to conventional standards
1\. QALYs gained, and cost-per-QALY gained
6 months
Contact the study team to confirm eligibility.
Radiation Oncology Queensland - Toowoomba
Toowoomba, Queensland, Australia
Adelaide Radiotherapy Centre
Adelaide, South Australia, Australia
WP Holman Clinic - Royal Hobart
Hobart, Tasmania, 7000, Australia
WP Holman Clinic - Launceston
Launceston, Tasmania, 7250, Australia
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, 3220, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 8006, Australia
Alfred Hospital
Prahran, Victoria, 3181, Australia
Primary Completion
May 2012
Actual (reported)Study Completion
June 2012
Actual (reported)Last Updated
February 13, 2013
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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