Assessment of New Radiation Oncology Technologies and Treatments
Condition: Prostate Cancer (Post Prostatectomy); Anal Cancer; Nasopharyngeal Cancer; Intermediate Risk Prostate Cancer
MeSH terms: Prostatic Neoplasms; Anus Neoplasms; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
Study type: Observational

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 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.
    

Detailed description: 
      The ANROTAT study is divided into four tumour site specific studies. A decision analytic
      model will be constructed for each disease area/technology 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.

      Participant's 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 QoL/toxicity 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
      events/toxicity, 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 QoL/toxicity evaluation, and
      healthcare resource usage. This involves the collection of data from 30 patients. Data
      collection includes eligibility, adverse events/toxicity, 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 QoL/toxicity 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 events/toxicity, 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 QoL/toxicity evaluation, and healthcare resource
      usage. This involves the collection of data from 30 prospective patients.

      Data collection includes eligibility, adverse events/toxicity, 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.
    

Intervention name(s): Non-Interventional Study
Intervention type(s): Other
Intervention description(s): This is a non-interventional study
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        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
      
Keywords: Prostate; Head and Neck; Anal