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:

  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 Summary:

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. 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