NCT00470236

Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast

A Randomised Phase III Study of Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,608 (actual)
• Sponsor: Trans Tasman Radiation Oncology Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hypotheses: 1. The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast). 2. The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm. 3. A molecular signature predictive of invasive recurrence of DCIS will be detectable and the molecular signature may eventually have clinical utility for therapy individualization. Overall Objectives: 1. To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy. 2. To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.

Detailed description

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.

Conditions

• Carcinoma, Ductal, Breast

Interventions

Type	Name	Description
RADIATION	Standard WB fractionation	A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
RADIATION	Shorter WB fractionation	A total dose of 42.5 Gy in 16 fractions in 2.656-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
RADIATION	Standard WB fractionation+Boost	Whole Breast: A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight). Tumour bed: A total dose of 10 Gy in 5 fractions in 2-Gy daily fractions, 5 fractions per week.
RADIATION	Shorter WB fractionation + Boost	Whole breast: A total dose of 42.5 Gy in 16 fractions in 2.656-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight). Tumour bed: A total dose of 10 Gy in 4 fractions in 2.5-Gy daily fractions, 4 fractions per week.

Timeline

• Start date: 2007-06-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2007-05-07
• Last updated: 2023-03-22

Locations

120 sites across 11 countries: Australia, Belgium, Canada, France, Ireland, Italy, Netherlands, New Zealand, Singapore, Switzerland, United Kingdom