Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000523505
Ethics application status
Approved
Date submitted
18/12/2003
Date registered
18/12/2003
Date last updated
12/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Radiotherapy in Early Breast Cancer
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 03.05 - A phase III study of regional radiation therapy in early breast cancer to improve overall survival.
Secondary ID [1] 42 0
ClinicalTrials.gov: NCT00005957
Secondary ID [2] 43 0
National Cancer Institute of Canada (NCIC): MA.20
Secondary ID [3] 44 0
National Clinical Trials Registry: NCTR450
Universal Trial Number (UTN)
Trial acronym
TROG 03.05
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Node positive or high risk node negative early Breast Cancer 41 0
Condition category
Condition code
Cancer 48 48 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 2: Breast radiation plus regional radiation. A dose of 5000cGy in 25 fractons at a rate of 200cGy per day, five days a week for five weeks will be prescribed to the modified wide tangent fields (the upper 1st and 3rd interspace ipsilateral internal mammary, superclavicular and axillary nodes).
Intervention code [1] 1296 0
Treatment: Other
Comparator / control treatment
Arm 1: Standard Breast Radiation (control). A dose of 5000cGy in 25 fractons at a rate of 200cGy per day, five days a week for five weeks will be prescribed to the standard tangent fields.
Control group
Active

Outcomes
Primary outcome [1] 78 0
Overall survival
Timepoint [1] 78 0
Time from randomisation to the time of death from any cause (final analysis will be done on this outcome when 312 patients have died but they will be followed until death). The rest of the patients will only be followed until death but the information will be analysed at the time of 312 deaths.
Secondary outcome [1] 152 0
Compare the toxic effects of these regimens in these patients.
Timepoint [1] 152 0
Last week of radiation treatment, 3 and 9 months after the last dose of radiotherapy and then annually (until death). The analysis will be done at the point of 312 deaths but the information will be collected until death of all 1822.
Secondary outcome [2] 153 0
Compare the quality of life of patients.
Timepoint [2] 153 0
Last week of radiation treatment, 3 and 9 months after the last dose of radiotherapy and then annually (until the first distant recurrence).
Secondary outcome [3] 154 0
Compare cosmetic outcomes in patients.
Timepoint [3] 154 0
At 33 months (3 yrs) and 57 months (5 yrs) post radiotherapy.

Eligibility
Key inclusion criteria
Histologically proven invasive carcinoma of the breast and no evidence of metastatic disease.- Investigations, including ER receptor status, and chest x-ray, and any additional investigations to rule out metastatic disease performed within 9 months prior to randomization.- A history and physical exam including weight, performance status and measurement of upper andlower arm circumferences performed within 12 weeks prior to randomization.- A bilateral mammogram performed within 12 months prior to randomization.- Patients must have been treated with Breast conservation therapy (BCT) (eg. lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy and considered a candidate for breast radiation. - Patients must be at high risk of regional recurrence, due to 1) pathologically positive axillary nodes, or2) pathologically negative axillary nodes anda) primary tumor > 5 cm orb) primary tumor > 2 cm and <10 axillary nodes removed and one of the following: ER negative, Skarf-Bloom-Richardson (SBR) grade 3 or lymphovascular invasion.Note: Patients with sentinel node dissection are eligible if they are node negative but still meet thehigh risk criteria. However, if they are node positive, a level I and II axillary dissection must be performed.- Patients must be treated with adjuvant systemic treatment, either currently accepted chemotherapy and/or hormonal therapy. (Patients may also have planned chemotherapy concurrently with theirradiation therapy.)- Performance status must be Eastern Cooperative Onocology Group (ECOG) 0, 1, or 2.- Patients should be planned and started on radiation as soon as possible after randomization.- Protocol treatment (radiotherapy) must begin within 8 weeks of the completion of adjuvant chemotherapy, unless radiotherapy is given concurrently with chemotherapy (ie CMF), or within 16weeks of the last surgical procedure for patients receiving hormonal therapy only.Patient’s life expectancy is >5 years- Women of childbearing potential must be using adequate contraception while receiving radiotherapy.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical evidence prior to surgery of T4 or N2-3 disease (UICC, 1997)- Evidence of residual disease in the axilla following dissection.- Serious non-malignant disease (e.g., cardiovascular, renal, pulmonary, systemic lupus erythematosis-SLE, scleroderma) which would preclude definitive surgical or radiation treatment.Note: Radiation therapy may not be recommended for patients with connective tissue disorders such as Lupus or Scleroderma.- Currently pregnant or lactating.- Women of childbearing age must be using adequate contraception while on treatment.- Concurrent and previous malignancies except non melanoma skin cancer; carcinoma in situ of the cervix or endometrium; contralateral non-invasive breast cancer (unless previous radiation to the contralateral breast). Also, invasive carcinoma of the cervix, endometrium, colon, thyroid, and melanoma treated five years prior to study entry and presumed cured are permitted on study.- Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Factors: Number of positive nodes (0, 1-3, >3), Type of chemotherapy (anthracycline containing, other or none), Hormonal therapy (yes, no), Number of axillary nodes removed and Centre. Simple randomisation by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2003
Actual
3/06/2003
Date of last participant enrolment
Anticipated
Actual
4/01/2007
Date of last data collection
Anticipated
Actual
16/12/2016
Sample size
Target
1822
Accrual to date
Final
1832
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 5286 0
Canada
State/province [1] 5286 0

Funding & Sponsors
Funding source category [1] 68 0
Government body
Name [1] 68 0
Cancer Council Multistate Research Grant
Country [1] 68 0
Australia
Primary sponsor type
Other Collaborative groups
Name
National Cancer Institute of Canada (NCIC)
Address
10 Alcorn Avenue, Suite 200 Toronto, Ontario M4V 3B1
Country
Canada
Secondary sponsor category [1] 54 0
Other Collaborative groups
Name [1] 54 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 54 0
Edith St Waratah NSW 2298
Country [1] 54 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 500 0
Austin Health
Ethics committee address [1] 500 0
Ethics committee country [1] 500 0
Australia
Date submitted for ethics approval [1] 500 0
Approval date [1] 500 0
21/08/2003
Ethics approval number [1] 500 0
Ethics committee name [2] 501 0
Campbelltown Hospital
Ethics committee address [2] 501 0
Ethics committee country [2] 501 0
Australia
Date submitted for ethics approval [2] 501 0
Approval date [2] 501 0
16/09/2003
Ethics approval number [2] 501 0
Ethics committee name [3] 502 0
East Coast Cancer Centre
Ethics committee address [3] 502 0
Ethics committee country [3] 502 0
Australia
Date submitted for ethics approval [3] 502 0
Approval date [3] 502 0
26/06/2004
Ethics approval number [3] 502 0
Ethics committee name [4] 503 0
Liverpool Hospital
Ethics committee address [4] 503 0
Ethics committee country [4] 503 0
Australia
Date submitted for ethics approval [4] 503 0
Approval date [4] 503 0
15/10/2003
Ethics approval number [4] 503 0
Ethics committee name [5] 504 0
Mater QRI
Ethics committee address [5] 504 0
Ethics committee country [5] 504 0
Australia
Date submitted for ethics approval [5] 504 0
Approval date [5] 504 0
23/07/2003
Ethics approval number [5] 504 0
Ethics committee name [6] 505 0
Newcastle Mater Hospital
Ethics committee address [6] 505 0
Ethics committee country [6] 505 0
Australia
Date submitted for ethics approval [6] 505 0
Approval date [6] 505 0
28/01/2004
Ethics approval number [6] 505 0
Ethics committee name [7] 506 0
Peter MacCallum
Ethics committee address [7] 506 0
Ethics committee country [7] 506 0
Australia
Date submitted for ethics approval [7] 506 0
Approval date [7] 506 0
11/03/2003
Ethics approval number [7] 506 0
Ethics committee name [8] 507 0
Peter MacCallum Cancer Centre
Ethics committee address [8] 507 0
Ethics committee country [8] 507 0
Australia
Date submitted for ethics approval [8] 507 0
Approval date [8] 507 0
Ethics approval number [8] 507 0
Ethics committee name [9] 508 0
Princess Alexandra Hospital
Ethics committee address [9] 508 0
Ethics committee country [9] 508 0
Australia
Date submitted for ethics approval [9] 508 0
Approval date [9] 508 0
27/06/2003
Ethics approval number [9] 508 0
Ethics committee name [10] 509 0
Royal Adelaide Hospital
Ethics committee address [10] 509 0
Ethics committee country [10] 509 0
Australia
Date submitted for ethics approval [10] 509 0
Approval date [10] 509 0
15/09/2003
Ethics approval number [10] 509 0
Ethics committee name [11] 510 0
Royal Brisbane Hospital
Ethics committee address [11] 510 0
Ethics committee country [11] 510 0
Australia
Date submitted for ethics approval [11] 510 0
Approval date [11] 510 0
22/08/2003
Ethics approval number [11] 510 0
Ethics committee name [12] 511 0
Royal Perth Hospital
Ethics committee address [12] 511 0
Ethics committee country [12] 511 0
Australia
Date submitted for ethics approval [12] 511 0
Approval date [12] 511 0
25/08/2003
Ethics approval number [12] 511 0
Ethics committee name [13] 512 0
Sir Charles Gairdner Hospital
Ethics committee address [13] 512 0
Ethics committee country [13] 512 0
Australia
Date submitted for ethics approval [13] 512 0
Approval date [13] 512 0
15/07/2003
Ethics approval number [13] 512 0
Ethics committee name [14] 513 0
St George Hospital
Ethics committee address [14] 513 0
Ethics committee country [14] 513 0
Australia
Date submitted for ethics approval [14] 513 0
Approval date [14] 513 0
18/02/2004
Ethics approval number [14] 513 0
Ethics committee name [15] 514 0
Westmead Hospital
Ethics committee address [15] 514 0
Ethics committee country [15] 514 0
Australia
Date submitted for ethics approval [15] 514 0
Approval date [15] 514 0
Ethics approval number [15] 514 0

Summary
Brief summary
Radiotherapy to the breast reduces the risk of cancer coming back for women with early breast cancer. This international study will determine if treating a larger area with radiotherapy can further improve the results.
Trial website
www.trog.com.au
Trial related presentations / publications
Whelan T.J, Olivotto I, Parulekar W, Ackerman I, Chua B, Nabid A, Vallis K, White J, Rousseau P, Fortin A, Pierce L, Manchul L, Chafe S, Nolan M, Craighead P, Bowen J, McCready D, Pritchard K, Gelmon K, Murray Y, Chapman J, Chen B, Levine, M. Regional nodal irradiation in early-stage breast cancer. New England Journal of Medicine. 2015 July;373(4): 307-316.
Public notes

Contacts
Principal investigator
Name 35336 0
Prof Timothy J. Whelan
Address 35336 0
Juravinski Cancer Centre
699 Concession Street
Hamilton, Ontario
L8V 5C2

Country 35336 0
Canada
Phone 35336 0
+1 905-387-9711, Ext. 64501
Fax 35336 0
Email 35336 0
[email protected]
Contact person for public queries
Name 10485 0
A/Prof Boon Chua
Address 10485 0
Cancer and Haematology Services
Medical Professional Unit
Level 1, South Wing, Edmund Blackett Building Prince of Wales Hospital, High Street, Randwick NSW 2031
Country 10485 0
Australia
Phone 10485 0
+61 2 9382 8873
Fax 10485 0
Email 10485 0
[email protected]
Contact person for scientific queries
Name 1413 0
A/Prof Boon Chua
Address 1413 0
Cancer and Haematology Services
Medical Professional Unit
Level 1, South Wing, Edmund Blackett Building Prince of Wales Hospital, High Street, Randwick NSW 2031
Country 1413 0
Australia
Phone 1413 0
+61 2 9382 8873
Fax 1413 0
Email 1413 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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