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Trial registered on ANZCTR


Registration number
ACTRN12607000238471
Ethics application status
Approved
Date submitted
18/04/2007
Date registered
4/05/2007
Date last updated
16/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Accelerated Partial Breast Irradiation for Early Breast Cancer
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 06.02 - A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation (APBI) Using Three-Dimensional Conformal Radiation Therapy for Early Breast Cancer to test the feasibility of APBI.
Secondary ID [1] 361 0
Clinicaltrials.gov: NCT00418210
Universal Trial Number (UTN)
Trial acronym
TROG 06.02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 1774 0
Condition category
Condition code
Cancer 1860 1860 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Accelerated partial breast irradiation (APBI) to region of tumour bed
3-dimensional conformal radiation therapy (3D CRT) 38.5 Gy in 3.85 Gy fractions over 5 consecutive working days
Intervention code [1] 1708 0
Treatment: Other
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2639 0
Feasibility rate of APBI using 3D conformal radiation therapy - Proportion of eligible patients treated without a major protocol deviation.
Major Deviations:
a. Overall treatment time is more than 10 days
b. Maximum dose (in a volume of = 2 cm3) to PTV_EVAL is more than 110% of the
prescribed dose
c. 90% of the prescribed dose covers less than 90% of the PTV_EVAL on DVH
d. 85% of the prescribed dose covers less than 99% of the PTV_EVAL
e. Maximum dose to critical normal structures is more than 105% of the specified values.
Timepoint [1] 2639 0
Measured over the whole duration of the study. The outcome is determined at the end of the study which is until all patients have been treated with APBI (from the data coollected over the whole duration of the study).
Secondary outcome [1] 4481 0
Radiation toxicity - The National Cancer Institute Common Terminology Criteria version 3.0 will be used for serious adverse event and toxicity reporting.
Timepoint [1] 4481 0
Will be measured at Last day of RT & 6 weeks post RT, 3 and 6 months post RT, then on a yearly basis until 10 years post RT.
Secondary outcome [2] 4482 0
Cosmetic outcome - Cosmetic outcome will be assessed using the following instruments: European Organisation for Research and Treatment of Cancer Cosmetic Rating System and Quantitative assessment of breast cosmesis.
Timepoint [2] 4482 0
Will be measured at 1 year, 2 years, 3 years and 5 years post Radiotherapy (RT).
Secondary outcome [3] 4483 0
Quality of life.
Timepoint [3] 4483 0
Will be measured at Last day of RT & 6 weeks post RT, 3 and 6 months post RT, then on a yearly basis until death.
Secondary outcome [4] 4484 0
Time to ipsilateral breast recurrence - The time from start of APBI to the time of invasive or intraductal recurrence in any soft tissue of the ipsilateral breast.
Timepoint [4] 4484 0
Will be measured at Last day of RT & 6 weeks post RT, 3 and 6 months post RT, then on a yearly basis until 10 years post RT.
Secondary outcome [5] 4485 0
Disease free survival - The time from start of APBI to recurrence of any form.
Timepoint [5] 4485 0
Will be measured at Last day of RT & 6 weeks post RT, 3 and 6 months post RT, then on a yearly basis until 10 years post RT.
Secondary outcome [6] 4486 0
Overall survival - The time from start of APBI to the time of death from any cause.
Timepoint [6] 4486 0
Will be measured at Last day of RT & 6 weeks post RT, 3 and 6 months post RT, then on a yearly basis until 10 years post RT.

Eligibility
Key inclusion criteria
Patients must fulfil all of the following criteria for admission to study:- Women aged >= 50 years.- Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology.- Bilateral mammograms performed within 6 months prior to registration.- Treated with breast conserving surgery (primary excision or re-excision) with negative radial resection margins of >= 2 mm* for both the invasive and if present, associated intraductal tumour.*Patients with superficial or deep resection margin of < 2 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.- Unifocal tumour measuring <= 20 mm in maximum microscopic dimension.- Negative nodal status determined by sentinel node biopsy, axillary dissection, or for women >70 years of age, clinical examination.- No evidence of distant metastasis.- Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy.- Ability to tolerate protocol therapy.- Protocol therapy must commence no later than 12 weeks from the last surgical procedure or 8 weeks from the last dose of chemotherapy.- Availability for long-term follow-up.- Women of child-bearing potential must use adequate contraception during RT.- Written informed consent.
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who fulfil any of the following criteria are not eligible for admission to study:- Multifocal or multicentric tumours.- Clinical or pathologic evidence of any of the following tumour features: extension to chest wall (excluding pectoralis muscle); oedema (including peau d’orange) or ulceration of skin; satellite skin nodules confined to the same breast; and inflammatory carcinoma.- Presence of extensive intraductal component (ductal carcinoma in situ occupying > 25% of the primary invasive tumour and present adjacent to the primary tumour).- Node-positive breast cancer determined by sentinel node biopsy, axillary dissection, or in women > 70 years of age, clinical examination.- Inability to localise surgical cavity on CT scans with no evidence of a surgical cavity, seroma or surgical clips delineating the tumour bed.- Treatment target volume estimated to occupy > 25% of the ipsilateral whole breast volume - Synchronous or metachronous bilateral invasive or intraductal breast cancer.- Locally recurrent breast cancer.- Ipsilateral breast implant.- Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).- Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix or endometrium treated five years prior to study entry.- Women who are pregnant or lactating.- Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2007
Actual
29/08/2007
Date of last participant enrolment
Anticipated
Actual
16/05/2008
Date of last data collection
Anticipated
1/06/2018
Actual
20/08/2018
Sample size
Target
48
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment outside Australia
Country [1] 5493 0
New Zealand
State/province [1] 5493 0

Funding & Sponsors
Funding source category [1] 2009 0
Government body
Name [1] 2009 0
National Health & Medical Research Council Project Grant
Country [1] 2009 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group (TROG)
Address
Edith St Waratah NSW 2298
Country
Australia
Secondary sponsor category [1] 291464 0
None
Name [1] 291464 0
Address [1] 291464 0
Country [1] 291464 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3732 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 3732 0
Melbourne VIC
Ethics committee country [1] 3732 0
Australia
Date submitted for ethics approval [1] 3732 0
Approval date [1] 3732 0
16/01/2007
Ethics approval number [1] 3732 0
Ethics committee name [2] 3733 0
Royal North Shore
Ethics committee address [2] 3733 0
St Leonards, NSW
Ethics committee country [2] 3733 0
Australia
Date submitted for ethics approval [2] 3733 0
Approval date [2] 3733 0
Ethics approval number [2] 3733 0
Ethics committee name [3] 3734 0
Calvary Mater Newcastle
Ethics committee address [3] 3734 0
Waratah, NSW
Ethics committee country [3] 3734 0
Australia
Date submitted for ethics approval [3] 3734 0
Approval date [3] 3734 0
Ethics approval number [3] 3734 0
Ethics committee name [4] 3735 0
Princess Alexandra Hospital
Ethics committee address [4] 3735 0
Wooloongabba, QLD
Ethics committee country [4] 3735 0
Australia
Date submitted for ethics approval [4] 3735 0
Approval date [4] 3735 0
Ethics approval number [4] 3735 0
Ethics committee name [5] 3736 0
Auckland Hospital
Ethics committee address [5] 3736 0
Auckland, NZ
Ethics committee country [5] 3736 0
New Zealand
Date submitted for ethics approval [5] 3736 0
Approval date [5] 3736 0
Ethics approval number [5] 3736 0
Ethics committee name [6] 3737 0
Waikato Hospital
Ethics committee address [6] 3737 0
Hamilton, NZ
Ethics committee country [6] 3737 0
New Zealand
Date submitted for ethics approval [6] 3737 0
Approval date [6] 3737 0
Ethics approval number [6] 3737 0
Ethics committee name [7] 6992 0
Royal Perth
Ethics committee address [7] 6992 0
Perth, WA
Ethics committee country [7] 6992 0
Australia
Date submitted for ethics approval [7] 6992 0
Approval date [7] 6992 0
Ethics approval number [7] 6992 0

Summary
Brief summary
This is a TROG multicentre feasibility study of APBI using 3D CRT in selected women with node-negative breast cancer treated by breast conserving surgery with negative margins.
This is a one-arm feasibility study in which the primary endpoint is the feasibility rate for APBI using 3D CRT. This is defined as the proportion of eligible patients treated without a major protocol deviation. Secondary endpoints include radiation toxicity, cosmetic outcome, quality of life, time to ipsilateral breast recurrence, disease-free survival and overall survival.
Primary objectives: To evaluate the technical feasibility and reproducibility of APBI limited to the region of the tumour bed using 3D CRT following breast conserving surgery.
Secondary objectives:
- To assess the acute and long term toxicity of APBI using 3D CRT.
- To examine the cosmetic outcome of women with breast cancer treated by breast conserving surgery and APBI using 3D CRT.
- To determine the time to ipsilateral breast recurrence, disease free survival and overall survival of women with node-negative breast cancer completely resected by breast conserving surgery followed by APBI using 3D CRT.
- To assess the quality of life of women with node-negative breast cancer treated by breast conserving surgery and APBI using 3D CRT
Trial website
https://trog.com.au/TROG-0602
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27811 0
Prof Boon Chua
Address 27811 0
Nelune Comprehensive Cancer Centre
Level 1, Bright Building, Prince of Wales Hospital
Barker Street, Randwick, NSW 2031, Australia
Country 27811 0
Australia
Phone 27811 0
+61 2 93825117
Fax 27811 0
+61 3 9656 1424
Email 27811 0
[email protected]
Contact person for public queries
Name 10897 0
Patrick Wheeler
Address 10897 0
Level 5 MHA Building
Calvary Mater Newcastle
Edith Street
Waratah NSW 2310
Country 10897 0
Australia
Phone 10897 0
+61 2 40143904
Fax 10897 0
+61 2 40143902
Email 10897 0
[email protected]
Contact person for scientific queries
Name 1825 0
Boon Chua
Address 1825 0
Nelune Comprehensive Cancer Centre
Level 1, Bright Building, Prince of Wales Hospital
Barker Street, Randwick, NSW 2031, Australia
Country 1825 0
Australia
Phone 1825 0
+61 2 93825117
Fax 1825 0
+61 3 9656 1424
Email 1825 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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