Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156130
Status:
COMPLETED
Last Update Posted:
2016-05-09
First Post:
2005-09-08
Brief Title:
Accelerated Radiotherapy Outcomes in Women
Sponsor:
Ontario Clinical Oncology Group OCOG
Organization:
Ontario Clinical Oncology Group OCOG
Study Overview
Official Title:
Accelerated Radiotherapy Outcomes in Women Long Term Outcomes of a Randomized Trial of Breast Irradiation Schedules After Lumpectomy in Women With Node-Negative Breast CancerAROW
Status:
COMPLETED
Status Verified Date:
2015-06
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:
None
Brief Summary:
This study is evaluating the long-term outcomes of women in a randomized trial that compared accelerated whole breast irradiation 425 Gy in 16 fractions over 22 days to a longer conventional schedule of whole breast irradiation 50 Gy in 25 fractions over 35 days following breast-conserving surgery The outcomes evaluated will include cosmetic outcome and cardiac disease as a measure of late radiation morbidity and local breast recurrence as a measure of effectiveness
Detailed Description:
This study is evaluating the long-term outcomes of women in a randomized trial that compared accelerated whole breast irradiation 425 Gy in 16 fractions over 22 days to a longer conventional schedule of whole breast irradiation 50 Gy in 25 fractions over 35 days following breast-conserving surgery The results reported at 5 years demonstrated equivalence for these two different radiation schedules for the effect of local recurrence in the breast and cosmetic outcome Emerging data has suggested that accelerated or shorter radiation schedules may potentially be associated with an increased risk of late morbidity of the skin soft tissue and the heart at 10 years and beyond The purpose of this study is to evaluate the long term outcomes of women randomized in the trial The outcomes evaluated will include cosmetic outcome and cardiac disease as a measure of late radiation morbidity and local breast recurrence as a measure of effectiveness
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 |
|---|---|---|---|
| CBCRI-Grant-014366 | None | None | None |