Trial Review

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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] 279655 0
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) 285460 0
Anal Cancer 285461 0
Nasopharyngeal Cancer 285462 0
Intermediate Risk Prostate Cancer 285463 0
Condition category
Condition code
Cancer 285645 285645 0 0
Other cancer types
Cancer 285646 285646 0 0
Bowel - Anal
Cancer 285936 285936 0 0
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] 283939 0
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] 286200 0
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] 286200 0
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] 286201 0
Obtain data on the impact of disease and treatment on QoL
Timepoint [2] 286201 0
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] 286202 0
Compare the resource usage associated with the planning and delivery of the new technologies compared to the conventional standard approaches
Timepoint [3] 286202 0
During data analysis
Secondary outcome [1] 295376 0
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] 295376 0
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?
No
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] 4905 0
5000
Recruitment postcode(s) [2] 4906 0
3081
Recruitment postcode(s) [3] 4907 0
2605
Recruitment postcode(s) [4] 4908 0
2310
Recruitment postcode(s) [5] 4909 0
3220
Recruitment postcode(s) [6] 4910 0
2521
Recruitment postcode(s) [7] 4911 0
7250
Recruitment postcode(s) [8] 4912 0
1871
Recruitment postcode(s) [9] 4913 0
2450
Recruitment postcode(s) [10] 4914 0
0820
Recruitment postcode(s) [11] 4915 0
4102
Recruitment postcode(s) [12] 4916 0
8006
Recruitment postcode(s) [13] 4917 0
2031
Recruitment postcode(s) [14] 4918 0
6014
Recruitment postcode(s) [15] 4919 0
7001
Recruitment postcode(s) [16] 4920 0
4350
Recruitment postcode(s) [17] 4921 0
3002
Recruitment postcode(s) [18] 4922 0
2050
Recruitment postcode(s) [19] 4923 0
3181

Funding & Sponsors
Funding source category [1] 284438 0
Government body
Name [1] 284438 0
Department of Health and Ageing
Country [1] 284438 0
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] 283361 0
None
Name [1] 283361 0
Address [1] 283361 0
Country [1] 283361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286583 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 286583 0
Ethics committee country [1] 286583 0
Australia
Date submitted for ethics approval [1] 286583 0
Approval date [1] 286583 0
10/05/2011
Ethics approval number [1] 286583 0
11/04/20/4.07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33573 0
Prof Professor Bryan Burmeister
Address 33573 0
Cancer Services Princess Alexandra Hospital Ipswich Rd Wolloongabba QLD, 4102
Country 33573 0
Australia
Phone 33573 0
+61 7 3240 6581
Fax 33573 0
Email 33573 0
[email protected]
Contact person for public queries
Name 16820 0
Rebecca Montgomery
Address 16820 0
TROG Central Operations Office
Department of Radiation Oncology
Calvary Mater Newcastle
Locked Bag 7
Hunter Region Mail Centre
NSW 2310
Country 16820 0
Australia
Phone 16820 0
+61 2 401 43910
Fax 16820 0
+61 2 40143618
Email 16820 0
[email protected]
Contact person for scientific queries
Name 7748 0
Professor Bryan Burmeister
Address 7748 0
Cancer Services
Princess Alexandra Hospital
Ipswich Rd
Wolloongabba
QLD, 4102
Country 7748 0
Australia
Phone 7748 0
+61 7 3240 6581
Fax 7748 0
Email 7748 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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