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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01379872




Registration number
NCT01379872
Ethics application status
Date submitted
8/06/2011
Date registered
23/06/2011
Date last updated
13/02/2013

Titles & IDs
Public title
Assessment of New Radiation Oncology Technologies and Treatments
Scientific title
The Assessment of New Radiation Oncology Technologies and Treatments (ANROTAT) TROG Research Project TRP11.A
Secondary ID [1] 0 0
TRP.11A
Universal Trial Number (UTN)
Trial acronym
ANROTAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer (Post Prostatectomy) 0 0
Anal Cancer 0 0
Nasopharyngeal Cancer 0 0
Intermediate Risk Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Bowel - Anal
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Non-Interventional Study

Study Protocol A - IMRT Post Prostatectomy - Prospective TROG 08.03 (RAVES) Participants
Prospective Participants (NOT participating in TROG 08.03 (RAVES))
Retrospective TROG 08.03 (RAVES) Participants
Participating in dosimetric evaluation and toxicity/QoL study
Participating in dosimetric evaluation only

Study Protocol B - IMRT Anal Cancer - Retrospective Patient Datasets
Prospective Participants (dosimetric evaluation and toxicity/QoL study)

Study Protocol C - IMRT Nasopharynx - Retrospective Patient Datasets
Prospective Participants (dosimetric evaluation and toxicity/QoL study)
Post-Treatment Prospective Participants (toxicity/QoL and cost study)

Study Protocol D - IGRT Intact Prostate - Patients with prostate cancer
- A sample of 30 patients from at least 10 centres that are to be treated for intermediate risk prostate cancer will be enrolled. The sample will be selected to comprise at least 10 patients that will undergo non-IGRT, 10 that will undergo IGRT with fiducials and planar imaging, and 10 that will undergo IGRT with volumetric imaging.


Other interventions: Non-Interventional Study
This is a non-interventional study

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison of dosimetry between treatment plans prepared using IMRT/IGRT vs 3DCRT/Non IGRT as a surrogate for effectiveness and safety. - Measured By:
Tumour control estimated from surrogate physical dose endpoints with each of the new technologies as compared with standard therapy.
The likelihood of acute or long term damage to organ/tissue and resultant likelihood of impairment of function or QoL estimated from surrogate physical dose endpoints with each of the new technologies as compared with standard therapy.
Timepoint [1] 0 0
6 Months
Primary outcome [2] 0 0
Obtain Data on the impact of disease and treatment on QoL - Measured by
QALYs gained, and cost-per-QALY gained
The likely cost increases or savings resulting from differences in acute or long term toxicity.
Timepoint [2] 0 0
6 months
Primary outcome [3] 0 0
Compare the resource usage associated with the planning and delivery of the new technologies compared to the conventional standard approaches - The differences in time and resources required for preparation, planning, quality assurance (QA) checking and treatment for each of the new technologies as compared with standard therapy.
The likely cost increases or savings associated with differences in time and resources involved in the management of patients with each of the new technologies as compared with standard therapy.
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
Synthesise the data obtained for objectives 1-3 together with information from previous studies and expert opinion to estimate the safety, clinical efficacy and cost-effectiveness of new technologies compared to conventional standards - 1. QALYs gained, and cost-per-QALY gained
Timepoint [4] 0 0
6 months

Eligibility
Key inclusion criteria
Study Protocol A: IMRT versus 3DCRT in Post-Prostatectomy Inclusion Criteria

All of the following must apply:

- Patient has provided written informed consent

- 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 = 1.0 ng/ml following RP

- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1

- Sufficient knowledge of English and adequate cognitive function to be able to complete
the QoL and other questionnaires

- 18 years or older
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

None of the following must apply:

- 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 >1.0 ng/ml

- Co-morbidities that would interfere with the completion of treatment

- Concurrent cytotoxic medication

- Hip prosthesis

Study Protocol B: IMRT versus 3DCRT in Anal Cancer Inclusion Criteria

All of the following must apply:

- Informed consent for prospective patients (QoL component)

- 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

- 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.

Exclusion Criteria

None of the following must apply:

- 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

Study Protocol C: IMRT versus 3DCRT in Nasopharynx Inclusion Criteria

All of the following must apply:

- Informed consent for prospective patients (QoL component)

- Age >18 years

- 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

- 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).

- Disease must be considered potentially curable by chemoradiation

- Patients must be medically fit for cisplatin chemotherapy according to local practice
(adequate renal, cardiac function, no significant neurological co-morbidities)

- Performance status ECOG 0, 1 or 2.

Exclusion Criteria

- Previous head and neck RT or major surgery

- Prior chemotherapy < 6 months from study entry

Study Protocol C: IGRT versus non-IGRT in Intact Prostate Inclusion Criteria

- Patient has provided written informed consent

- 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 < 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 = 6, PSA 10.1-20.0
ng/ml; T2b-c, Gleason =6, PSA = 20.0 ng/ml; T1-2, Gleason 7, PSA = 20.0 ng/ ml)

Exclusion Criteria

- 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

- Previous or current use of AD

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Illawarra Cancer Care Centre - Wollongong
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [8] 0 0
Radiation Oncology Queensland - Toowoomba - Toowoomba
Recruitment hospital [9] 0 0
Adelaide Radiotherapy Centre - Adelaide
Recruitment hospital [10] 0 0
WP Holman Clinic - Royal Hobart - Hobart
Recruitment hospital [11] 0 0
WP Holman Clinic - Launceston - Launceston
Recruitment hospital [12] 0 0
Andrew Love Cancer Care Centre, Geelong Hospital - Geelong
Recruitment hospital [13] 0 0
Austin Health - Heidelberg
Recruitment hospital [14] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [15] 0 0
Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
1871 - Liverpool
Recruitment postcode(s) [3] 0 0
2298 - Newcastle
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment postcode(s) [7] 0 0
4102 - Brisbane
Recruitment postcode(s) [8] 0 0
- Toowoomba
Recruitment postcode(s) [9] 0 0
- Adelaide
Recruitment postcode(s) [10] 0 0
7000 - Hobart
Recruitment postcode(s) [11] 0 0
7250 - Launceston
Recruitment postcode(s) [12] 0 0
3220 - Geelong
Recruitment postcode(s) [13] 0 0
3084 - Heidelberg
Recruitment postcode(s) [14] 0 0
8006 - Melbourne
Recruitment postcode(s) [15] 0 0
3181 - Prahran

Funding & Sponsors
Primary sponsor type
Other
Name
Trans-Tasman Radiation Oncology Group (TROG)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The Trans Tasman Radiation Oncology Group (TROG) has been commissioned by the Department of
Health and Ageing 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 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 (and current) 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 site specific
regions:

A. Post Prostatectomy(IMRT) B. Anal Cancer (IMRT) C. Nasopharynx (IMRT) D. Intermediate Risk
Prostate Cancer (IGRT)

The aims of the site specific components of the ANROTAT protocol are as follows:

Protocol A. Develop an approach for applying the Framework to evaluate the safety, clinical
efficacy and cost-effectiveness of IMRT compared to 3DCRT in patients with prostate cancer
(PP).

Protocol B. Develop an approach for applying the Framework to evaluate the safety, clinical
efficacy and cost-effectiveness of IMRT compared to 3DCRT in AC.

Protocol C. Develop an approach for applying the Framework to evaluate the safety, clinical
efficacy and cost-effectiveness of IMRT compared to 3DCRT in NPC.

Protocol D. Develop an approach for applying the Framework to evaluate the safety, clinical
efficacy and cost-effectiveness of IGRT compared to non-IGRT in patients with intermediate
risk prostate cancer.
Trial website
https://clinicaltrials.gov/show/NCT01379872
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bryan Burmeister
Address 0 0
Trans-Tasman Radiation Oncology Group (TROG)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications