Assesment of New Radiation Oncology Technologies and Treatments

The assessment of New Radiation Oncology Technologies and treatments (ANROTAT) in Post Prostatectomy, Anal Cancal, Nasopharynx and Intact Prostate (TRP11.A)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12612000168853

Acronym

ANROTAT (TRP 11.A)

Enrollment

138

Registered

2012-02-06

Start date

2011-06-20

Completion date

2012-04-30

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Department of Health and Ageing and the Radiation Oncology professions recognised that there was a need for the Medicare Benefits Schedule (MBS) to support appropriate new radiation oncology technologies and treatments as they become available, to ensure optimal patient care. The ANROTAT projects aim is to develop and test a generic research framework able to collect and generate information to assess the safety, clinical efficacy and cost effectiveness of new radiation therapy technologies and treatments. This framework will then be used to assess the safety, clinical efficacy and cost effectiveness of; a) Intensity Modulated Radiation Therapy (IMRT) vs Three-Dimensional Conformal Radiation Therapy (3DCRT) in prostate (post prostactomy), anal and nasopharyngeal cancer b) Image Guided Radiation Therapy (IGRT) vs non-IGRT in patient with intermediate risk prostate cancer Information will be collected on the participant’s treatment, individual experience and costs associated with their treatment, which will be used in comparing the existing and new types of radiation therapy treatment methods currently available in Australian Treatment Centres. It is hypothesised that the new technologies; - produce treatment plans with improved dosimetric properties shown through reduced toxicity without unacceptable loss of efficacy as compared to plans produced using conventional standards - have the potential to optimise tumour dose and improve tumour control without causing unacceptable levels of toxicity as compared to treatment using conventional standards. - are cost-effective compared to conventional standards The ultimate aim of the ANROTAT study is to make the most effective radiation therapy treatment methods available to all cancer patients in Australia. The ANROTAT project is a non-interventional prospective evaluation of clinical activity. It is therefore defined as a clinical audit rather than a clinical trial.

Interventions

The Trans Tasman Radiation Oncology Group (TROG) has been commissioned by the Department of Health and Ageing (DoHA) 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 (MBS) 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 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 sites. The two new radiation oncology technologies being assessed are; 1) Intensity-Modulated Radiation Therapy (IMRT); which is the method used to vary the fluence within a photon beam to achieve a highly conformal dose distribution to the target volume and minimise dose to surrounding organs at risk (OAR). The fluence modulations are inversely calculated using an optimisation process to produce a prescribed 3D dose distribution. “Inverse treatment planning” defines the desired dose to target and critical structures as a starting point, and intensity-modulated beam arrangements are derived to “acceptably” approach or meet these desired dose limits. At least single-point dose constraints, but more commonly a multipoint description of dose–volume limits, drive the process”.1 The modulated beams are delivered using time variant apertures defined by multi-leaf collimators (MLC). The term ‘IMRT’ for the purpose of the project refers to standard IMRT delivered by a fixed gantry. This definition excludes ‘rotational’ IMRT delivered by single or multiple arcs (e.g. RapidArc) and Volumetric Arc Therapy (VMAT) (e.g. Tomotherapy). 2) Image Guided Radiation Therapy; is radiation therapy based on imaging acquired at the point of treatment delivery with the intent to ensure geometric accuracy of radiation delivery. In this context, IGRT must be able to provide information of the target itself. For the purpose of the ANROTAT project, IGRT is defined as daily imaging with on-line decision making that at a minimum allows for daily patient re-positioning based on imaging of the target volume or an appropriate surrogate marker. Two options exist: a) Planar imaging using electronic portal imaging (EPI) or kilo-voltage (kV) on-board imaging. In this case, the implantation of fiducial markers into the prostate gland is required. b) Volumetric imaging using one of various CT systems. kV and MV Cone Beam (CB) CT are allowed. Ultrasound methods are not permitted in the present protocol. IGRT for the ANROTAT project will focus on intact prostate imaging i.e. daily orthogonal planar imaging with fiducial markers or volumetric (e.g. CBCT) imaging. The source data collected for this second stage of the project will be taken from patient medical records, reports, RT plans and QOL/Cost questionniares. As retrospective participants registered in this study have to have completed RT treatment with the last 60 months before registration, the year range the data will be collected is from 2006-2011.

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

All protocols: - Patient has provided written informed consent - Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires Protocol A (Post Prostatectomy): - Prior Radical Prostatectomy for adenocarcinoma of the prostate. - Histological confirmation of adenocarcinoma of the prostate with the Gleason score reported (RP specimen). - Patients must have at least one of the following risk factors: - Positive margins - Extraprostatic extension (EPE) with or without seminal vesicle involvement (pT3a or pT3b)PSA nadir less than or equal to 1.0 ng/ml following RP - ECOG performance status 0 – 1 - Patients participating in the Toxicity and QoL evaluation QoL data must be scheduled to undergo RT or must have completed RT within the previous 12 months Protocol B (Anal Canal): - Histological confirmation of squamous cell carcinoma or basaloid carcinoma within the past 6 weeks - T2-4N0, TanyN2 (ipsilateral groin nodes) and TanyN3 (bilateral groin nodes) - Intention to elective irradiate all pelvic nodal groups up to L5-S1 interspace (including mesorectal, presacral, internal iliac, external iliac, ischiorectal fossa, obturator and inguinal groups) - Planned for radical chemoradiation Protocol C (Nasopharynx): - Histologically confirmed carcinoma of the nasopharynx, types WHO1-111, Stage I-IVB within the past 6 weeks - Adequate staging of local disease and exclusion of distant metastatic disease within the past 6 weeks. - Disease must be considered potentially curable by chemoradiation - Patients must be medically fit for cisplatin chemotherapy according to local practice - Performance status ECOG 0, 1 or 2. - Patients participating in the cross sectional study of QoL must have completed radiation therapy treatment within 18-30 months prior to the date of informed consent (or 60 months in selected sites) Protocol D (Intact Prostate): - Histological diagnosis of carcinoma of the prostate less than or equal to 6 months of entry without evidence of metastatic disease to the lymph nodes, bone or lung - Intermediate risk prostate cancer (that is, T1-2a, Gleason score less than or equal to 6, PSA 10.1-20.0 ng/ml; T2b-c, Gleason less than or equal to 6, PSA less than or equal to 20.0 ng/ml; T1-2, Gleason 7, PSA less than or equal to 20.0 ng/ ml)

Exclusion criteria

Protocol A (Post Prostatectomy): - Previous pelvic RT or surgery ie previous rectal or bladder resection - Concurrent or previous malignancy within 5 years prior to registration (except non-melanomatous skin cancer) - Androgen deprivation (AD) prior to or following RP as this will affect QoL - Evidence of nodal or distant metastases - Clinical or imaging evidence of local recurrence - Planned adjuvant RT to cover pelvic lymph nodes - PSA greater than 1.0 ng/ml - Co-morbidities that would interfere with the completion of treatment - Concurrent cytotoxic medication - Hip prosthesis Protocol B (Anal Canal): - Evidence of metastatic disease - Prior pelvic RT/ surgery (e.g. vaginal hysterectomy) - Presence of hip prosthesis - Acquired immunodeficiency syndrome (AIDS). HIV patients without AIDS eligible. - Previous pelvic cancers Protocol C (Nasopharynx): - Previous head and neck RT or major surgery - Prior chemotherapy less than or equal to 6 months from study entry Protocol D (Intact Prostate): - Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection. - Previous pelvic RT or surgery (eg abdomino-perineal resection) - Hip prosthesis - Inflammatory bowel disease

Outcome results