Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Neoplasms

Breast Carcinoma In Situ

Breast Diseases

Skin Diseases

Whole Breast RT alone - Standard fractionation schedule (50GY/25 Fractions/35days)

Whole Breast RT alone - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days)

Whole Breast RT + tumor bed boost - Standard fractionation schedule (50 Gy/25 fractions/35 days; Boost 16 Gy/8 fractions/10 days)

Whole breast RT + tumour bed boost - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days; Boost 16 Gy/8 fractions/10 days)

A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).

Standard 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).

Shorter WB fractionation

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.

Standard 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.

Shorter WB fractionation + Boost

Boon Chua

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast	NCT00470236	Carcinoma, Duct...	Standard WB fra... Shorter WB frac... Standard WB fra... Shorter WB frac...	18 Years -	Trans Tasman Radiation Oncology Group
Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast	NCT00470236	Carcinoma, Duct...	Standard WB fra... Shorter WB frac... Standard WB fra... Shorter WB frac...	18 Years -	Trans Tasman Radiation Oncology Group

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