Trial Information

The Assessment of New Radiation Oncology Technologies and Treatments (ANROTAT) TROG Research Project TRP11.A

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.