Ignite Creation Date:
2024-05-05 @ 11:38 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01379872
Status:
COMPLETED
Last Update Posted:
2013-02-13
First Post:
2011-06-08
Brief Title:
Assessment of New Radiation Oncology Technologies and Treatments
Sponsor:
Trans Tasman Radiation Oncology Group
Organization:
Trans Tasman Radiation Oncology Group
Study Overview
Official Title:
The Assessment of New Radiation Oncology Technologies and Treatments ANROTAT TROG Research Project TRP11A
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANROTAT
Brief Summary:
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 ProstatectomyIMRT 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
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 ProstatectomyIMRT 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
Detailed Description:
The ANROTAT study is divided into four tumour site specific studies A decision analytic model will be constructed for each disease areatechnology to estimate the safety clinical efficacy and cost effectiveness of the new technology compared to conventional standard treatment approach This will incorporate information from previous studies and data from a series of component studies including a dosimetric evaluation a QoL evaluation and an evaluation of the cost of treatment planning and delivery The development and refinement of these models is an integral component of the planned research program The overall protocol details the data collection activities that have been identified as feasible and useful for informing the development of a series of decision analytic models to evaluate IMRT and IGRT for the four specified cancers
These activities involve the collection of dosimetry data quality of life QoL and toxicity data and health care resource usage data in a series of component studies These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of the decision analytic models
Data will be collected from at least 10 treatment centres for each of the site specific studies Data will be transcribed onto CRFs from source data forms The CRFs will be sent to TROG Cancer Research on a secure fax line
Participants treatment plans will be securely uploaded to the TROG Central Quality Management System CQMS for plan review
The data to be collected number of participants and tasks for participants is outlined below for each of the site specific studies WBRC has been invited to participate in Studies A and B only however ethics approval is sought for the entire ANROTAT protocol so our centre has approval and the option to participate in all components of ANROTAT where required
Study Protocol A IMRT versus 3DCRT in Post Prostatectomy
The post prostatectomy study methodology applies the ANROTAT framework and includes a series of component studies including a dosimetric evaluation a QoLtoxicity evaluation and an evaluation of the cost of treatment planning and delivery This involves the collection of data from approximately 30 patients Data collection includes eligibility adverse eventstoxicity QoL patient costs and dosimetry parameters contouring planning quality assurance treatment data These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of a decision analytic model
Centres will be asked to provide two retrospective and one prospective patient but this will have to be varied according to the availability of retrospective patients at each participating centre Each centre will be provided with details of case selection
Data collected directly from patients will include QoL and toxicity data as well as costs incurred by the patient as a result of their treatment
Study Protocol B IMRT versus 3DCRT in Anal Cancer
The anal canal study methodology applies the ANROTAT framework and includes a series of component studies including a dosimetric evaluation a QoLtoxicity evaluation and healthcare resource usage This involves the collection of data from 30 patients Data collection includes eligibility adverse eventstoxicity QoL patient costs and dosimetry parameters contouring planning quality assurance treatment data These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of a decision analytic model
Participating centres will be asked to provide data on the contouring and planning of a CT data set that will be sent to each of the participating centres Following this each participating centre will plan 3 retrospective patient cases each In addition to this data will be collected from 10 prospective anal cancer patients who will be asked to complete QoL and patient cost questionnaires
Study Protocol C IMRT versus 3DCRT in NPC
The nasopharynx study methodology applies the ANROTAT framework and includes a series of component studies including a dosimetric evaluation a QoLtoxicity evaluation and healthcare resource usage This involves the collection of data from 30 patients for the dosimetry component and 150 patients for the QoL component
Data collection includes eligibility adverse eventstoxicity QoL patient costs and dosimetry parameters contouring planning quality assurance treatment data These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of a decision analytic model
Participating centres will be asked to provide data on the contouring of a CT data set that will be sent to each of the participating centres Following this the dosimetry component will require centres to recruit as many prospective patients as possible to collect the above mentioned data Due to the short time frame if 30 prospective patients cannot be recruited in the time frame this will be supplemented with retrospective cases In addition to this data will be collected from 150 nasopharynx patients who will be asked to complete QoL and patient cost questionnaires
Study Protocol D IGRT versus non IGRT in Intermediate Risk Prostate Cancer
The IGRT study methodology applies the ANROTAT framework and includes a series of component studies including a dosimetric evaluation a QoLtoxicity evaluation and healthcare resource usage This involves the collection of data from 30 prospective patients
Data collection includes eligibility adverse eventstoxicity QoL patient costs and dosimetry parameters These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of a decision analytic model
Data collected directly from patients will include QoL and toxicity data as well as costs incurred by the patient as a result of their treatment
These activities involve the collection of dosimetry data quality of life QoL and toxicity data and health care resource usage data in a series of component studies These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of the decision analytic models
Data will be collected from at least 10 treatment centres for each of the site specific studies Data will be transcribed onto CRFs from source data forms The CRFs will be sent to TROG Cancer Research on a secure fax line
Participants treatment plans will be securely uploaded to the TROG Central Quality Management System CQMS for plan review
The data to be collected number of participants and tasks for participants is outlined below for each of the site specific studies WBRC has been invited to participate in Studies A and B only however ethics approval is sought for the entire ANROTAT protocol so our centre has approval and the option to participate in all components of ANROTAT where required
Study Protocol A IMRT versus 3DCRT in Post Prostatectomy
The post prostatectomy study methodology applies the ANROTAT framework and includes a series of component studies including a dosimetric evaluation a QoLtoxicity evaluation and an evaluation of the cost of treatment planning and delivery This involves the collection of data from approximately 30 patients Data collection includes eligibility adverse eventstoxicity QoL patient costs and dosimetry parameters contouring planning quality assurance treatment data These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of a decision analytic model
Centres will be asked to provide two retrospective and one prospective patient but this will have to be varied according to the availability of retrospective patients at each participating centre Each centre will be provided with details of case selection
Data collected directly from patients will include QoL and toxicity data as well as costs incurred by the patient as a result of their treatment
Study Protocol B IMRT versus 3DCRT in Anal Cancer
The anal canal study methodology applies the ANROTAT framework and includes a series of component studies including a dosimetric evaluation a QoLtoxicity evaluation and healthcare resource usage This involves the collection of data from 30 patients Data collection includes eligibility adverse eventstoxicity QoL patient costs and dosimetry parameters contouring planning quality assurance treatment data These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of a decision analytic model
Participating centres will be asked to provide data on the contouring and planning of a CT data set that will be sent to each of the participating centres Following this each participating centre will plan 3 retrospective patient cases each In addition to this data will be collected from 10 prospective anal cancer patients who will be asked to complete QoL and patient cost questionnaires
Study Protocol C IMRT versus 3DCRT in NPC
The nasopharynx study methodology applies the ANROTAT framework and includes a series of component studies including a dosimetric evaluation a QoLtoxicity evaluation and healthcare resource usage This involves the collection of data from 30 patients for the dosimetry component and 150 patients for the QoL component
Data collection includes eligibility adverse eventstoxicity QoL patient costs and dosimetry parameters contouring planning quality assurance treatment data These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of a decision analytic model
Participating centres will be asked to provide data on the contouring of a CT data set that will be sent to each of the participating centres Following this the dosimetry component will require centres to recruit as many prospective patients as possible to collect the above mentioned data Due to the short time frame if 30 prospective patients cannot be recruited in the time frame this will be supplemented with retrospective cases In addition to this data will be collected from 150 nasopharynx patients who will be asked to complete QoL and patient cost questionnaires
Study Protocol D IGRT versus non IGRT in Intermediate Risk Prostate Cancer
The IGRT study methodology applies the ANROTAT framework and includes a series of component studies including a dosimetric evaluation a QoLtoxicity evaluation and healthcare resource usage This involves the collection of data from 30 prospective patients
Data collection includes eligibility adverse eventstoxicity QoL patient costs and dosimetry parameters These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of a decision analytic model
Data collected directly from patients will include QoL and toxicity data as well as costs incurred by the patient as a result of their treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None