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Trial registered on ANZCTR


Registration number
ACTRN12607000246482
Ethics application status
Approved
Date submitted
4/05/2007
Date registered
8/05/2007
Date last updated
10/11/2024
Date data sharing statement initially provided
23/03/2023
Date results information initially provided
23/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Radiation doses and fractionation schedules in non-low risk Ductal Carcinoma In Situ (DCIS) of the breast.
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 07.01 - A randomised phase III study of radiation doses and fractionation schedules in non-low risk Ductal Carcinoma In Situ (DCIS) of the breast to improve time to recurrence
Secondary ID [1] 251979 0
Breast International Group (BIG) 3-07
Secondary ID [2] 251980 0
ClinicalTrials.gov ID NCT00470236
Universal Trial Number (UTN)
Trial acronym
DCIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Completely excised non-low risk DCIS 1785 0
Condition category
Condition code
Cancer 1871 1871 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women will be randomised to receive one of the following four treatments:
- Whole breast RT alone using standard fractionation schedule 50 Gy / 25 fractions over 35 days
- Whole breast RT alone using shorter fractionation schedule 42.5 Gy / 16 fractions over 22 days
- Whole breast RT plus tumour bed boost using standard fractionation schedule - 50 Gy / 25 fractions over 35 days plus 10 Gy / 5 fractions over 5 days
- Whole breast RT plus tumour bed boost using shorter fractionation schedule - 42.5 Gy / 16 fractions over 22 days plus 10 Gy / 4 fractions over 4 days
Intervention code [1] 1709 0
Treatment: Other
Comparator / control treatment
Whole breast RT alone using standard fractionation schedule 50 Gy / 25 fractions over 35 days
Control group
Dose comparison

Outcomes
Primary outcome [1] 2659 0
Time to local recurrence - The time from randomisation to the time of recurrent invasive or intraductal disease in any soft tissue of the ipsilateral breast.
Timepoint [1] 2659 0
Main analysis after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up.
Secondary outcome [1] 4509 0
Overall survival
Timepoint [1] 4509 0
The time from randomisation to the time of death from any cause. Main analysis after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up.
Secondary outcome [2] 4510 0
Time to disease recurrence
Timepoint [2] 4510 0
The time from randomisation to the time of any recurrence. Main analysis after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up.
Secondary outcome [3] 4511 0
Cosmetic outcome
Timepoint [3] 4511 0
Cosmetic outcome will be assessed using the following instruments: EORTC Cosmetic Rating System and Quantitative assessment of breast cosmesis. Assessed at baseline, 12, 36 and 60 months post Radiotherapy.
Secondary outcome [4] 4512 0
Radiation toxicity - The NCI
Timepoint [4] 4512 0
Assessed at baseline, last week of RT, 3, 6, and 12 months post RT and then yearly until year 10.
Secondary outcome [5] 4513 0
Common Terminology Criteria version 3.0 will be used for serious adverse event and toxicity reporting.
Timepoint [5] 4513 0
Assessed at baseline, last week of RT, 3, 6, and 12 months post RT and then yearly until year 10.
Secondary outcome [6] 4514 0
Quality of life
Timepoint [6] 4514 0
Assessed at baseline, last week of RT, 3, 6, and 12 months post RT and then yearly until year 10.

Eligibility
Key inclusion criteria
1. Women aged >18years.
2. Histologically proven DCIS of the breast without an invasive component.
3. Bilateral mammograms performed within 6 months prior to randomisation.
3. Clinically node-negative.
4. Treated by breast conserving surgery (primary excision or re-excision) with complete microscopic excision and clear radial margins of greater than or equal to 1mm (Patients with superficial or deep resection margin of <1 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia)
5. Women who are at high risk of local recurrence due to: Age < 50 years; OR Age = 50 years plus at least one of the following: a) Symptomatic presentation
b) Palpable tumour c) Multifocal disease
d) Microscopic tumour size = 1.5 cm in maximum dimension e) Intermediate or high nuclear grade f) Central necrosis
g) Comedo histology h) Radial* surgical resection margin < 10 mm*Patients with superficial or deep resection margin of < 10 mm are eligible if surgery has not removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.
6. Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy including whole breast RT.
7. Ability to tolerate protocol treatment.
8. Protocol RT should preferably commence within 8 weeks but must commence no later than 12 weeks from the last surgical procedure
9. ECOG performance status 0, 1 or 2.
10. Patient’s life expectancy > 5 years
11. Availability for long-term follow-up.
12. Written informed consent.
Minimum age
18 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:-
1. Multicentric disease or extensive microcalcifications that could not be completely excised by breast conserving surgery with radial margins of greater than or equal to 1mm (Patients with superficial and/or deep margin of < 1mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia)
2. Presence of tumour cells in lymph nodes detected using H&E or immunohistochemical examination (if lymph node biopsy or dissection has been performed).
3. Locally recurrent breast cancer.
4. Previous DCIS or invasive cancer of the contralateral breast.
5. Other concurrent or previous malignancies except: a) Non-melanomatous skin cancer; b) Carcinoma in situ of the cervix or endometrium; and
c) Invasive carcinoma of the cervix, endometrium, colon, thyroid and melanoma treated at least five years prior to study admission without disease recurrence.
6. Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).- 7. ECOG performance status = 3.
8. Women who are pregnant or lactating.

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 by phone /computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Factors: Age (< 50, = 50), Surgical margin (< 1 mm, = 1 mm), Endocrine therapy (yes, no), centre
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
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2007
Actual
25/06/2007
Date of last participant enrolment
Anticipated
1/10/2014
Actual
30/06/2014
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
1600
Accrual to date
Final
1608
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 5272 0
New Zealand
State/province [1] 5272 0
Country [2] 5273 0
Canada
State/province [2] 5273 0
Country [3] 5274 0
Netherlands
State/province [3] 5274 0
Country [4] 5275 0
United Kingdom
State/province [4] 5275 0
Country [5] 5276 0
Ireland
State/province [5] 5276 0
Country [6] 5277 0
Switzerland
State/province [6] 5277 0
Country [7] 26711 0
Singapore
State/province [7] 26711 0
Country [8] 26712 0
Belgium
State/province [8] 26712 0
Country [9] 26713 0
France
State/province [9] 26713 0
Country [10] 26714 0
Italy
State/province [10] 26714 0

Funding & Sponsors
Funding source category [1] 2018 0
Government body
Name [1] 2018 0
National Health & Medical Research Council Project Grant
Country [1] 2018 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group Ltd
Address
Department of Radiation Oncology
Calvary Mater Newcastle
Locked Bag 7 Hunter Region Mail Centre
NSW 2310
Country
Australia
Secondary sponsor category [1] 320117 0
None
Name [1] 320117 0
Address [1] 320117 0
Country [1] 320117 0
Other collaborator category [1] 1201 0
Other Collaborative groups
Name [1] 1201 0
Breast International Group (BIG)
Address [1] 1201 0
Institut Jules Bordet
Blvd de Waterloo 121, 7th fl
B-1000 Brussels
Country [1] 1201 0
Belgium
Other collaborator category [2] 1202 0
Other Collaborative groups
Name [2] 1202 0
Address [2] 1202 0
Department of Surgical Oncology
Calvary Mater Newcastle
Locked Bag 7 Hunter Region Mail Centre
NSW 2310
Country [2] 1202 0
Australia
Other collaborator category [3] 1203 0
Other Collaborative groups
Name [3] 1203 0
European Organisation for Research and Treatment of Cancer
Address [3] 1203 0
EORTC AISBL / IVZW
Avenue Mounieriaan, 83/11
Brussel 1200 Bruxelles
Country [3] 1203 0
Belgium
Other collaborator category [4] 1204 0
Other Collaborative groups
Name [4] 1204 0
Canadian Cancer Trials Group
Address [4] 1204 0
New other collaborator address. Please modify.
Country [4] 1204 0
Canada
Other collaborator category [5] 279147 0
Other Collaborative groups
Name [5] 279147 0
International Breast Cancer Study Group
Address [5] 279147 0
Effingerstrasse 40
3008 Bern
Switzerland
Country [5] 279147 0
Switzerland
Other collaborator category [6] 279148 0
Other Collaborative groups
Name [6] 279148 0
Cancer Trials Ireland
Address [6] 279148 0
60 Fitzwilliam Square, Dublin 2, Ireland
Country [6] 279148 0
Ireland
Other collaborator category [7] 279149 0
Other Collaborative groups
Name [7] 279149 0
Scottish Cancer Trials Breast Group
Address [7] 279149 0
1 South Gyle Crescent,
Edinburgh EH12 9EB,
Country [7] 279149 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3745 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 3745 0
Peter MacCallum Cancer Centre St Andrews Place East Melbourne, VIC 3002
Ethics committee country [1] 3745 0
Australia
Date submitted for ethics approval [1] 3745 0
Approval date [1] 3745 0
04/05/2007
Ethics approval number [1] 3745 0

Summary
Brief summary
Aims
- To refine treatment selection for women with non-low risk DCIS to optimise disease control & minimise toxicity
- Clinical: To evaluate outcomes after breast conserving surgery by investigating two factors
- Addition of tumour bed boost to whole breast RT
- Dose fractionation
- QoL To compare QoL, psychological distress, perceived risk of invasive disease & perceived cosmetic outcomes amongst treatment arms
- Biological: To identify biomarkers/molecular signatures of DCIS predictive of invasive recurrence for therapy individualisation
Trial website
https://trog.com.au/TROG-0701-DCIS
Trial related presentations / publications
07.01 (DCIS): A randomised phase III study of radiation doses and fractionation schedules for ductal carcinoma in situ (DCIS) of the breast

Presented by Boon Chua at the Breast International Group Specific Meeting, Vienna, Austria March 2017

Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3-07/TROG 07.01): a randomised, factorial, multicentre, open-label, phase 3 study. Lancet 2022;400(10350):431-440. doi: 10.1016/S0140-6736(22)01246-6. Epub 2022 Aug 6.
Chua BH, Link EK, Kunkler IH, Whelan TJ, Westenberg AH, Gruber G, Bryant G, Ahern V, Purohit K, Graham PH, Akra M, McArdle O, O'Brien P, Harvey JA, Kirkove C, Maduro JH, Campbell ID, Delaney GP, Martin JD, Vu T TT, Muanza TM, Neal A, Olivotto IA, BIG 3-07/TROG 07.01 trial investigators.
Public notes

Contacts
Principal investigator
Name 27812 0
Prof Boon Chua
Address 27812 0
Medical Professorial Unit
Level 1, South Wing, Edmund Blackett Building
Prince of Wales Hospital, High Street, Randwick, NSW 2031
Country 27812 0
Australia
Phone 27812 0
+61 (0) 2 9382 8873
Fax 27812 0
Email 27812 0
[email protected]
Contact person for public queries
Name 10898 0
Kristy Odelli
Address 10898 0
TROG Cancer Research
PO Box 88
Waratah, NSW 2298
Country 10898 0
Australia
Phone 10898 0
+61 2 401 43911
Fax 10898 0
+61 2 401 43902
Email 10898 0
[email protected]
Contact person for scientific queries
Name 1826 0
Boon Chua
Address 1826 0
Medical Professorial Unit
Level 1, South Wing, Edmund Blackett Building
Prince of Wales Hospital, High Street, Randwick, NSW 2031
Country 1826 0
Australia
Phone 1826 0
+61 (0) 2 9382 8873
Fax 1826 0
Email 1826 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No decision made yet by TMC


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.