CompletedPhase 3ACTRN12607000246482

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


Sponsor

Trans Tasman Radiation Oncology Group Ltd

Enrollment

1,600 participants

Start Date

Jun 25, 2007

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares different radiation dose schedules for treating ductal carcinoma in situ (DCIS), a non-invasive form of breast cancer that has a higher risk of returning. It is for women aged 18 and older with confirmed DCIS that does not contain an invasive cancer component. Participants are randomly assigned to one of the radiation schedules after breast surgery and followed to see which approach best prevents recurrence.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 usi

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)

Ireland

Switzerland

Singapore

Belgium

France

Italy

New Zealand

Canada

Netherlands

United Kingdom

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ACTRN12607000246482