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.