Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000749909
Ethics application status
Approved
Date submitted
18/07/2011
Date registered
18/07/2011
Date last updated
18/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised study of image guided radiotherapy for prostate carcinoma with and without endorectal balloon.
Scientific title
A randomised study of image guided radiotherapy (IGRT) for prostate carcinoma with and without endorectal balloon to compare treatment related morbidity and quality of life.
Secondary ID [1] 259884 0
Nil
Universal Trial Number (UTN)
Trial acronym
ERB trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate carcinoma 265477 0
Condition category
Condition code
Cancer 265630 265630 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Investigational arm: insertion of endorectal balloon during image guided radiotherapy. An endorectal balloon is inserted into the rectum prior to the radiation treatment to the prostate each day and inflated with 100mls of air and removed at the end of treatment each day.
Intervention code [1] 264307 0
Treatment: Devices
Comparator / control treatment
Control arm: image guided radiotherapy alone. This treatment is the standard treatment offered for prostate cancer control and does not include insertion of the endorectal balloon each day.
Control group
Active

Outcomes
Primary outcome [1] 262418 0
Image guided radiotherapy treatment with endorectal balloon results in less treatment related morbidity and impairment of quality of life compared with image guided radiotherapy alone.
Timepoint [1] 262418 0
Less treatment related morbidity and impairment of QOL- Lent Soma and QLQC30 and QLQ-PR25: Baseline, End of Treatment, 6 week, 3 month, 6 month, 9 month, 1 year, 18 month, 2 year, 30 month and 3 year.
Primary outcome [2] 262419 0
Using the endorectal balloon results in better radiation dose distributions to the rectal and anal walls.
Timepoint [2] 262419 0
Dose volume histograms: End of treatment
Secondary outcome [1] 273739 0
Quantify and compare radiation-induced changes in anorectal function using anorectal manometry to compare parameters of anorectal function and radiation dose distribution in the rectal and anal walls with and without the use of the endorectal balloon.
Timepoint [1] 273739 0
Anorectal Manometry: baseline, 6 weeks, 1 year, 2 year and 3 year
Secondary outcome [2] 273740 0
Monitor treatment efficacy based on clinical, radiological and serum PSA evaluation at pre-determined intervals after completion of therapy.
Timepoint [2] 273740 0
Serum PSA: Baseline, 3 months, 6 months, 9 months, 1 year, 18 months, 2 years, 30 months, 3 years.

Eligibility
Key inclusion criteria
Localised prostate cancer T1a - T3b, N0, M0
Any gleason score
PSA equal to or less than 30 micrograms/L
ECOG 0-2
Signed informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
-Metastatic cancer of the prostate or disease involving organs such as the bladder and rectum - T4, N0,M0
-ECOG equal to or greater than 3.
-Constant requirement for medication likely to interfere with evaluation of anorectal motility such as anti-diarrhoeal or opiate analgesic drugs.
-Haemorrhoids greater than or equal to grade II (as evaluated using Common Terminology Criteria for Adverse Events V3.0
-Colitis equal to or greater than Grade II (as evaluated using Common Terminology Criteria for Adverse Events V3.0
-Any other anorectal disease that the clinician feels would interfere with the tolerance of the ERB during IGRT such as fissures, fistulas or abscesses.
-Previous radiation therapy to the pelvis.
- No signed informed consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be introduced to the trial at their initial clinic visit with the radiation oncologist. They will be reseen at the CT Simulator planning appointment so any questions will be answered and then they can sign the consent form if they wish. The patient will be enrolled using a eligibility questionnaire to check that they fulfil the inclusion/exclusion criteria.

Allocation is not concealed although a person not involved in the trial will be allocating patients to either group of the trial to prevent bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be allocated an arm of the trial via a spreadsheet using permuted blocks by someone not involved in the trial management or administration of trial procedures.

random block allocation downloaded from http://www.graphpad.com/quickcalcs/randomize2.cfm this has then been saved into an excel spreadsheet.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264769 0
Other Collaborative groups
Name [1] 264769 0
RANZCR Radiation Oncology faculty
Country [1] 264769 0
Australia
Primary sponsor type
Individual
Name
Professor Eric Yeoh
Address
Radiation Oncology
Royal Adelaide Hospital
Level 3 East Wing
North Terrace
ADELAIDE SA 5000
Country
Australia
Secondary sponsor category [1] 266511 0
Commercial sector/Industry
Name [1] 266511 0
NL-Tec Pty Ltd
Address [1] 266511 0
Supplier
NL-Tec Pty Ltd
PO Box 226, Willetton,
Western Australia 6955
Country [1] 266511 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266746 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 266746 0
Ethics committee country [1] 266746 0
Australia
Date submitted for ethics approval [1] 266746 0
Approval date [1] 266746 0
15/03/2011
Ethics approval number [1] 266746 0
110208

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

Contacts
Principal investigator
Name 32411 0
Address 32411 0
Country 32411 0
Phone 32411 0
Fax 32411 0
Email 32411 0
Contact person for public queries
Name 15658 0
Professor Eric Yeoh
Address 15658 0
Radiation Oncology
Level 3 East Wing
Royal Adelaide Hospital
North Terrace
ADELAIDE SA 5000
Country 15658 0
Australia
Phone 15658 0
61 8 82224815
Fax 15658 0
61 8 82222016
Email 15658 0
[email protected]
Contact person for scientific queries
Name 6586 0
Professor Eric Yeoh
Address 6586 0
Radiation Oncology
Level 3 East Wing
Royal Adelaide Hospital
North Terrace
ADELAIDE SA 5000
Country 6586 0
Australia
Phone 6586 0
61 8 82224815
Fax 6586 0
61 8 82222016
Email 6586 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.