Radiation doses and fractionation schedules in non-low risk Ductal Carcinoma In Situ (DCIS) of the breast.
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
Trans Tasman Radiation Oncology Group Ltd
1,600 participants
Jun 25, 2007
Interventional
Conditions
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
Eligibility
Plain Language Summary
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Interventions
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
Locations(10)
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ACTRN12607000246482