Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00470236
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-22
First Post:
2007-05-03
Brief Title:
Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ DCIS of the Breast
Sponsor:
Trans Tasman Radiation Oncology Group
Organization:
Trans Tasman Radiation Oncology Group
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DCIS
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
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 Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NHMRC 454390 | OTHER_GRANT | None | None |
| BIG 3-07 | OTHER | None | None |
| NCIC CTG MA33 | OTHER | None | None |
| BOOG 2009-03 | OTHER | None | None |
| ICORG 10-06 | OTHER | None | None |
| EORTC 22085-10083 | OTHER | None | None |
| IBCSG 38-10 | OTHER | None | None |
| SCTBG 2009MayPR55 | OTHER | Collaborative Group | None |