A Randomised Phase III Study of Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast
Specific objectives:
1. To evaluate time to local recurrence in women with DCIS treated with breast conserving
surgery followed by:
- whole breast RT alone versus whole breast RT plus tumour bed boost;
- RT using the standard fractionation schedule versus the shorter schedule.
2. To evaluate time to disease recurrence and overall survival in women with DCIS treated
with breast conserving surgery followed by:
- whole breast RT alone versus whole breast RT plus tumour bed boost;
- RT using the standard fractionation schedule versus the shorter schedule.
3. To compare the toxicity of:
- whole breast RT alone versus whole breast RT plus tumour bed boost;
- RT using the standard fractionation schedule versus the shorter schedule.
4. To compare the cosmetic outcome of:
- whole breast RT alone versus whole breast RT plus tumour bed boost;
- RT using the standard fractionation schedule versus the shorter schedule.
5. To identify a molecular signature predictive of invasive recurrence of DCIS to
facilitate therapy individualization.
6. To assess inter-relationship of biomarkers and relationship between biomarker
expression and specific histopathologic features of DCIS.
7. To evaluate the quality of life of women treated with:
- whole breast RT alone versus whole breast RT plus tumour bed boost;
- RT using the standard fractionation schedule versus the shorter schedule.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to local recurrence, measured from the date of randomization to the date of first evidence of local recurrence.
Main analysis after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up.
No
Boon Chua
Study Chair
Peter MacCallum Cancer Centre, Australia
Australia: Human Research Ethics Committee
TROG 07.01
NCT00470236
June 2007
November 2025
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