Clinical Trial: Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Randomised Phase III Study of Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast
Brief Summary:
Hypotheses:
- 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).
- The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm.
- 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:
- To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy.
- To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.
Detailed Summary:
Specific objectives:
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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.
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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.
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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.
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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.
- To identify a molecular signature predictive of invasive recurrence of DCIS to facilitate therapy individualization.
- Same as current
Current Secondary Outcome:
- Overall survival [ Time Frame: Measured from the date of randomization to the date of death from any cause. Main analysis of secondary outcomes after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up. ]
- Time to disease recurrence [ Time Frame: Measured from the date of randomization to the date of first evidence of recurrent disease. Main analysis of secondary outcomes after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up. ]
- Cosmetic Outcome [ Time Frame: Cosmetic assessment will take place at baseline, 12, 36 and 60 months post RT. ]
- Radiation toxicity [ Time Frame: Assessed at baseline, last week of RT, 3, 6, and 12 months post RT and then yearly until year 10. ]
- Quality of Life [ Time Frame: Assessed at baseline, last week of RT, 6, 12, 24, 60 & 120 months post RT. ]
Original Secondary Outcome:
- Overall survival [ Time Frame: Measured from the date of randomization to the date of death from any cause. Main analysis of secondary outcomes after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up. ]
- Time to disease recurrence [ Time Frame: Measured from the date of randomization to the date of first evidence of recurrent disease. Main analysis of secondary outcomes after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up. ]
- Cosmetic Outcome [ Time Frame: Cosmetic assessment will take place at baseline, 12, 36 and 60 months post RT. ]
- Radiation toxicity [ Time Frame: Assessed at baseline, last week of RT, 3, 6, and 12 months post RT and then yearly until year 10. ]
- Quality of Life [ Time Frame: Assessed at baseline, last week of RT, 3, 6, and 12 months post RT and then yearly until year 10. ]
Information By: Trans-Tasman Radiation Oncology Group (TROG)
Dates:
Date Received: May 3, 2007
Date Started: June 2007
Date Completion: June 2024
Last Updated: February 15, 2017
Last Verified: February 2017