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Trial registered on ANZCTR


Registration number
ACTRN12612000169842
Ethics application status
Approved
Date submitted
30/01/2012
Date registered
6/02/2012
Date last updated
3/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Assessment of New Radiation Oncology Technologies and Treatments Radiation Oncology Register Pilot
Scientific title
The assessment of New Radiation Oncology Technologies and treatments (ANROTAT) in Post Prostatectomy, Anal Cancal, Nasopharynx and Intact Prostate, Radiation Oncology Register Pilot (ARORP) TROG Research Project TRP11.B
Secondary ID [1] 279661 0
NIL
Universal Trial Number (UTN)
Trial acronym
ARORP (TRP 11.B)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer (Post Prostatectomy) 285471 0
Anal Cancer 285472 0
Nasopharyngeal Cancer 285473 0
Intermediate Risk Prostate Caner 285474 0
Condition category
Condition code
Cancer 285653 285653 0 0
Other cancer types
Cancer 285654 285654 0 0
Bowel - Anal
Cancer 285937 285937 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Department of Health and Ageing has asked the Trans Tasman Radiation Oncology Group (TROG) to develop and pilot a radiation oncology register as part of the ANROTAT (TRP 11.A) project (http://www.ANZCTR.org.au/ACTRN12612000168853.aspx).

The ARORP will include the development and testing of a set of data variables to capture demographics, diagnosis, staging, surgical treatments, quality of Life, follow-up and radiotherapy intervention related data. A cross sectional feedback survey of participating centre staff authorised to enter data into the ARORP will be undertaken to assess the feasibility of the collection of the data items in routine practice as well as the web-based registration, the user manual and the register in general.

Data will be collected in two groups of patients;
1. Prospective ANROTAT (TRP 11.A) study participants at or after the first follow-up visit
2. Patients who are attending for their annual follow-up appointment (including ANROTAT (TRP 11.A) retrospective patients and NON-ANROTAT patients).

The data will be collected from the patients medical records, reports, RT plans and from QoL Questionniares. Patients are to be within 60months of completion of RT treament on registration, therefore the year range of the information collected will be from 2006-2012.

The study population are patients who have undergone;
- Image Guided Radiation Therapy (IGRT) or non-IGRT in patient with intermediate risk prostate cancer
- Intensity Modulated Radiation Therapy (IMRT) or 3DCRT in patients with prostate cancer (post-proctectomy)
- IMRT or 3DCRT in patients with nasophargeal cancer
- IMRT or 3DRT in patients with anal cancer.

This project will be open for registering patients from December 2011 to March 2012.
Intervention code [1] 283942 0
Not applicable
Comparator / control treatment
This study is developing and testing a register so there is no comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286205 0
To assess the completeness and accuracy of the data collected using the online register system
Timepoint [1] 286205 0
End of project
Secondary outcome [1] 295385 0
To quantify the opions of system users regading the system's functionallity and the feasibility of the data collection in routine practice.
Timepoint [1] 295385 0
End of project

Eligibility
Key inclusion criteria
Post Prostatectomy;
- Patient has been provided with the Patient Information Sheet and has not opted-out of the ARORP.
- Prior RP 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0 – 1 prior to the course of RT that defines eligibility for the ARORP
- Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires
- 18 years or older
- Have received IMRT or 3DCRT RT Treatment

Anal Cancer;
- Patient has been provided with the Patient Information Sheet and has not opted-out of the ARORP.
- Age 18-80 years of age
- Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires
- Histological confirmation of squamous cell carcinoma or basaloid carcinoma prior to the course of RT that defines eligibility for the ARORP
- T2-4N0, TanyN2 (ipsilateral groin nodes) and TanyN3 (bilateral groin nodes).
- Have received IMRT or 3DCRT RT Treatment

Nasopharynx;
- Patient has been provided with the Patient Information Sheet and has not opted-out of the ARORP.
- Age 18 years or older
- Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires
- Histologically confirmed carcinoma of the nasopharynx, types WHO1-111, Stage I-IVB prior to the course of RT that defines eligibility for the ARORP
- Adequate staging of local disease (MRI of primary must be performed, imaging of neck nodes with CT with contrast and/or PET-CT) and exclusion of distant metastatic disease (to be confirmed by either whole body PET-CT or a chest CT, and upper abdominal CT or ultrasound scan for patients with abnormal liver function tests or a bone scan or FDG-PET for patients with bone pain) prior to the course of RT that defines eligibility for the ARORP
- Disease must have been considered potentially curable by chemoradiation prior to the course of RT that defines eligibility for the ARORP
- Performance status ECOG 0, 1 or 2 prior to the course of RT that defines eligibility for the ARORP
- Have received IMRT or 3DCRT RT Treatment

Intact Prostate;
- Patient has been provided with the Patient Information Sheet and has not opted-out of the ARORP.
- Aged 18 years or older
- Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires
- Histological diagnosis of carcinoma of the prostate less than or equal to 6 months prior to the course of RT that defines eligibility for the ARORP 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)
- Have received IMRT or 3DCRT RT Treatment
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Post Prostatectomy;
- Previous pelvic RT or surgery ie previous rectal or bladder resection prior to the course of RT that defines eligibility for the ARORP
- Concurrent 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
- Hip prosthesis prior to the course of RT that defines eligibility for the ARORP

Anal Cancer;
- Pelvic RT/ surgery (e.g. vaginal hysterectomy) prior to the course of RT that defines eligibility for the ARORP
- Presence of hip prosthesis prior to the course of RT that defines eligibility for the ARORP
- Acquired immunodeficiency syndrome (AIDS). HIV patients without AIDS eligible.
- Previous pelvic cancers prior to the course of RT that defines eligibility for the ARORP

Nasopharynx;
- Previous head and neck RT or major surgery prior to the course of RT that defines eligibility for the ARORP
- Chemotherapy less than or equal to 6 months from study entry prior to the course of RT that defines eligibility for the ARORP

Intact Prostate;
- Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection prior to the course of RT that defines eligibility for the ARORP
- Previous pelvic RT or surgery (eg abdomino-perineal resection) prior to the course of RT that defines eligibility for the ARORP
- Hip prosthesis prior to the course of RT that defines eligibility for the ARORP
- Inflammatory bowel disease prior to the course of RT that defines eligibility for the ARORP

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/01/2012
Actual
27/01/2012
Date of last participant enrolment
Anticipated
Actual
2/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4924 0
2145
Recruitment postcode(s) [2] 4925 0
0820
Recruitment postcode(s) [3] 4926 0
3181
Recruitment postcode(s) [4] 4927 0
2521
Recruitment postcode(s) [5] 4928 0
5000
Recruitment postcode(s) [6] 6320 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 284515 0
Government body
Name [1] 284515 0
Department of Health and Ageing
Country [1] 284515 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group
Address
Central Operations Office
Department of Radiation Oncology
Calvary Mater Newcastle
Locked Bag 7
Hunter Region Mail Centre
NSW 2310
Country
Australia
Secondary sponsor category [1] 283444 0
None
Name [1] 283444 0
Address [1] 283444 0
Country [1] 283444 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286584 0
Hunter New England Human Reseach Ethics Committee
Ethics committee address [1] 286584 0
Loked Bag 1
New Lambton
2305
NSw
Ethics committee country [1] 286584 0
Australia
Date submitted for ethics approval [1] 286584 0
Approval date [1] 286584 0
13/10/2011
Ethics approval number [1] 286584 0
LNR/11/HNE/363

Summary
Brief summary
The ANROTAT Radiation Oncology Register Pilot (ARORP) aims to assess the feasibility of using a practical system to collect accurate and complete treatment and outcome data for patients undergoing radiotherapy treatment for their cancer in the following indications:
- Intermediate risk prostate cancer treated with IGRT or non­IGRT
- Prostate Cancer ­ Post Prostatectomy treated with IMRT or 3DCRT
- Nasopharynx Cancer treated with IMRT or 3DCRT
- Anal Cancer treated with IMRT or 3DCRT DESIGN

There are two main design components to the ARORP:
1. An observational study in which data are entered into ARORP from a cohort of patients who received radiotherapy treatment for the indications described above
2. A cross­sectional surveys of users of the ARORP at participating centres

The opinions of ARORP users will be measured via an evaluation survey that asks for their rating (excellent, good, fair, or poor) of the system in terms of access, data entry, navigation, training, support, and overall ease of use. The proportion of users providing an overall rating of excellent or good will be calculated.

Focus group discussions with ARORP users also will be performed at each centre to obtain qualitative feedback on the system (including such things as the burden on the staff collecting the data).
Trial website
www.trog.com.au
Trial related presentations / publications
Trans Tasman Radiation Oncology Group. The assessment of new radiation oncology technologies and treatments (TRP 11.B ARORP). Final Protocol 25/08/2011, Amendment 1 31/08/2011
Public notes

Contacts
Principal investigator
Name 33577 0
Prof Professor Bryan Burmeister
Address 33577 0
Cancer Cervices Princess Alexandra Hospital Ipswich Rd Wolloongabba QLD, 4102
Country 33577 0
New Zealand
Phone 33577 0
+61 (0)7 3240 6581
Fax 33577 0
Email 33577 0
[email protected]
Contact person for public queries
Name 16824 0
Rebecca Montgomery
Address 16824 0
TROG Central Operations Office
Department of Radiation Oncology
Calvary Mater Newcastle
Locked Bag 7
Hunter Region Mail Centre
NSW 2310
Country 16824 0
Australia
Phone 16824 0
+61 2 40143910
Fax 16824 0
+61 40143902
Email 16824 0
[email protected]
Contact person for scientific queries
Name 7752 0
Professor Bryan Burmeister
Address 7752 0
Cancer Cervices
Princess Alexandra Hospital
Ipswich Rd
Wolloongabba
QLD, 4102
Country 7752 0
Australia
Phone 7752 0
+61 (0)7 3240 6581
Fax 7752 0
Email 7752 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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