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Trial registered on ANZCTR

Registration number

ACTRN12612000168853

Ethics application status

Approved

Date submitted

30/01/2012

Date registered

6/02/2012

Date last updated

24/11/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Assesment of New Radiation Oncology Technologies and Treatments

Scientific title

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

Secondary ID [1]

clincaltrials.gov identifier: NCT01379872

Universal Trial Number (UTN)

Trial acronym

ANROTAT (TRP 11.A)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prostate Cancer (Post Prostatectomy)

Anal Cancer

Nasopharyngeal Cancer

Intermediate Risk Prostate Cancer

Condition category

Condition code

Cancer

Other cancer types

Cancer

Bowel - Anal

Cancer

Prostate

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

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.

Intervention code [1]

Not applicable

Comparator / control treatment

IMRT and IGRT will be compared against Three-Dimensional Conformal Radiation Therapy (3DCRT) and non-IGRT treatments.

3DCRT is the use of three dimensional (3D) planning software and beam shaping devices such as multi-leaf collimators (MLC), to conform external photon beams to a target volume in three dimensions, whilst minimising dose to surrounding critical structures. 3DCRT is forward planned and based on a 3D dataset representing the patient, typically a computed tomography (CT) image set. Several types of algorithms are available to achieve the calculation of absorbed dose e.g. Pencil Beam, Superposition.
The forward planning process involves a set of conformal treatment fields, and the possible introduction of internal apertures, wedges, and/or additional beam directions to modify the dose distribution to avoid critical structures or boost certain regions of the target.

For the purpose of the ANROTAT project, non-IGRT is defined as any treatment approach that does not employ daily imaging of the target volume. Various imaging frequencies and off-line decision making models such as ‘No Action Level’ (NAL) or the ‘Newcastle model’ are acceptable. It is generally assumed that verification imaging is performed at least weekly and on-line action is typically restricted to gross misplacements.

The source data collected for this 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 regisrtation, the year range the data will be collected is from 2006-2011.

Control group

Active

Outcomes

Primary outcome [1]

Compare the dosimetry of treatment plans prepared using the new technologies against those prepared using the conventional standard approaches as a surrogate for effectiveness and safety

Timepoint [1]

Prospective participants: Plans produced before comencement of treatment
Retrospective participants and datasets: Plans produced before comencement of treatment (reproduced after registration for the purpose of the study).
All radiotherapy plans are due for submission by mid February 2012.

Primary outcome [2]

Obtain data on the impact of disease and treatment on QoL

Timepoint [2]

Propective participants: Baseline, during treatment (6 or 8 weeks) and post treatment (6weeks and/or 3 months) the exact timing depends on tumour type.
Retrospective participants: post treatment (more than or equal to 3 months post treatment)

Primary outcome [3]

Compare the resource usage associated with the planning and delivery of the new technologies compared to the conventional standard approaches

Timepoint [3]

During data analysis

Secondary outcome [1]

Synthesise the data obtained for objectives 1-3 together with information from previous studies and expert opinion into a decision analytic model to estimate the safety, clinical efficacy and cost-effectiveness of the new technologies compared to the conventional standards

Timepoint [1]

During data analysis

Eligibility

Key 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)

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Study design

Purpose

Duration

Selection

Defined population

Timing

Both

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

20/06/2011

Actual

20/06/2011

Date of last participant enrolment

Anticipated

Actual

30/04/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

120

Accrual to date

Final

138

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5000

Recruitment postcode(s) [2]

3081

Recruitment postcode(s) [3]

2605

Recruitment postcode(s) [4]

2310

Recruitment postcode(s) [5]

3220

Recruitment postcode(s) [6]

2521

Recruitment postcode(s) [7]

7250

Recruitment postcode(s) [8]

1871

Recruitment postcode(s) [9]

2450

Recruitment postcode(s) [10]

0820

Recruitment postcode(s) [11]

4102

Recruitment postcode(s) [12]

8006

Recruitment postcode(s) [13]

2031

Recruitment postcode(s) [14]

6014

Recruitment postcode(s) [15]

7001

Recruitment postcode(s) [16]

4350

Recruitment postcode(s) [17]

3002

Recruitment postcode(s) [18]

2050

Recruitment postcode(s) [19]

3181

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Health and Ageing

Address [1]

GPO Box 9848,
Canberra
ACT 2601

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

Trans Tasman Radiation Oncology Group Ltd

Address

Cantral Operations Office
Calvary Mater Newcastle
Locked bag 7
HRMC NSW 2310

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Locked Bag 1
New Lambton 
NSW
2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/05/2011

Ethics approval number [1]

11/04/20/4.07

Summary

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.

Trial website

www.trog.com.au

Trial related presentations / publications

Grand M, Amin R, Cornes DC, Duchesne G, Hall K, Kron T, Burmeister B The Assessment of New Radiation Oncology Technologies and Treatment (ANROTAT): The Design and Testing of a Generic Framework. ORAL Presentation RANZCR Perth 2010 ASM 14-17 October 2010. J Med Imaging & Rad Onc.  Vol. 54, S1, A65, Oct 2010.

Grand M, Amin R, Cornes DC, Duchesne G, Haworth A, Hall K, Kron T, Burmeister B.The assessment of new radiation oncology technology and treatments (ANROTAT): What is the value in developing a framework? Oral Presentation. Presenter: Mel Grand. Elekta Useres Group Meeting, Kingscliff, 28th-30th May 2010.

Grand M, Amin R, Cornes DC, Duchesne G, Hall K, Kron T, Burmeister B.The evaluation of new radiation oncology technology and treatments (ANROTAT): The development of a generic research framework. Oral Presentation. Presenter: Mel Grand. ASMMIRT 2010, Gold Coast, 9-12th September 2010.

Grand M, Amin R, Cornes D.A, Duchesne G, Haworth A, Kron T, Burmeister B. The role of Medical Physicists in Developing a Generic Research Framework for the Assessment of New Radiation Oncology Technology and Treatments in Radiation Oncology. Oral presentation. Presenting Author: Mel Grand. EPSM ABEC Meeting 2010, Melbourne, 5-9 December 2010. 

S Babington, J Dixon, M Ebert, F Foroudi, J Frantzis, M Grand, P Greer, M Hall, A Haworth, B Hilder, T Kron, C Lin, A Rolfo, and P Vial. What is the Value of Image Guidance in External Beam Radiotherapy? Oral presentation. Presenter: Tomas Kron. EPSM ABEC Meeting 2010, Melbourne, 5-9 December 2010

Haworth A, Grand M, Corry J, Jackson M, Ng M, Kron T, Burmeister B, Duchesne G. Assessment of New Radiation Oncology Technology and Treatments in Radiation Oncology – the  ANROTAT project and collection of IMRT specific data. Oral presentation. Presenter: A Haworth. EPSM ABEC Meeting 2010, Melbourne, 5-9 December 2010

Grand M, O’Brien P. “Obstacles to Participation in Randomised Cancer Clinical Trials: a systematic review of the literature". Journal of Medical Imaging and Radiation Oncology. Oct 2011.

Ms Mel Grand - The Development and Implementation of a Generic Research Framework for the Assessment of New Radiation Oncology Technology and Treatments (ANROTAT): Providing the Evidence for Future Change. Annual Scientific Meeting of Medical Imaging and Radiation Therapists (ASMMIRT) 2011.  

Ms Haylea Cleaver - Quality Assurance (QA) and Phantom Dosimetry Credentialing within the collaborative research environment; A unique opportunity for the Radiation Therapist, ASMMIRT 2011.

Ms Haylea Cleaver - A system for review of diagnostic imaging in radiotherapy clinical trial quality assurance and the development of technical specifications, ASMMIRT 2011.

Mel Grand - RANZCR ASM 2011 – Challenges in Bringing New Technology into Practice: The Development and Pilot of a Generic Research Framework for the Assessment of New Radiation Oncology Technology and Treatments (ANROTAT) – accepted for oral presentation

Tomas Kron - Engineering and Physical Sciences in Medicine and the Australian Biomedical Engineering Conference EPSM-ABEC 2011 (14-18/08/2011) - The TROG ANROTAT project – just another acronym?

Ms Mel Grand - The Development and Implementation of a Generic Research Framework for the Assessment of New Radiation Oncology Technology and Treatments (ANROTAT): Providing the Evidence for Future Change. Annual Scientific Meeting of Medical Imaging and Radiation Therapists (ASMMIRT) 2011.  

Grand M, O’Brien P. “Obstacles to Participation in Randomised Cancer Clinical Trials: a systematic review of the literature". Journal of Medical Imaging and Radiation Oncology. Oct 2011.

Public notes

Contacts

Principal investigator

Name

Prof Professor Bryan Burmeister

Address

Cancer Services Princess Alexandra Hospital Ipswich Rd Wolloongabba QLD, 4102

Country

Australia

Phone

+61 7 3240 6581

Fax

[email protected]

Contact person for public queries

Name

Rebecca Montgomery

Address

TROG Central Operations Office
Department of Radiation Oncology
Calvary Mater Newcastle
Locked Bag 7
Hunter Region Mail Centre
NSW 2310

Country

Australia

Phone

+61 2 401 43910

Fax

+61 2 40143618

[email protected]

Contact person for scientific queries

Name

Professor Bryan Burmeister

Address

Cancer Services
Princess Alexandra Hospital
Ipswich Rd
Wolloongabba
QLD, 4102

Country

Australia

Phone

+61 7 3240 6581

Fax

[email protected]

No information has been provided regarding IPD availability

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No Supporting Document Provided

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