Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084539
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2004-06-10
Brief Title:
Adjuvant Hypofractionated Intensity-Modulated Radiation Therapy With Incorporated Boost in Treating Patients With Early-Stage Breast Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase II Study of Hypofractionated Intensity Modulated Radiation Therapy IMRT With Incorporated Boost in Early Stage Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-03
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:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Hypofractionated fewer treatments than in standard radiation therapy intensity-modulated radiation therapy radiation directed at the tumor more precisely than in standard radiation therapy with incorporated boost an increase in the amount of radiation given during treatment may kill more tumor cells
PURPOSE This phase II trial is studying how well adjuvant hypofractionated intensity-modulated radiation therapy with incorporated boost works in treating patients with early-stage breast cancer
PURPOSE This phase II trial is studying how well adjuvant hypofractionated intensity-modulated radiation therapy with incorporated boost works in treating patients with early-stage breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the toxicity associated with adjuvant hypofractionated intensity-modulated radiotherapy using an incorporated boost in patients with early-stage breast cancer
Secondary
Determine the long-term cosmetic result and quality of life of patients treated with this regimen
Determine the long-term local control in patients treated with this regimen
OUTLINE Patients undergo adjuvant hypofractionated intensity-modulated radiotherapy with incorporated boost once daily 5 days a week for 4 weeks
Quality of life is assessed within 1 month of starting radiotherapy at 6 weeks after completion of radiotherapy and then every 6 months for 5 years
Patients are followed at 6 weeks and then every six months for 5 years
PROJECTED ACCRUAL A total of 37-74 patients will be accrued for this study
Primary
Determine the toxicity associated with adjuvant hypofractionated intensity-modulated radiotherapy using an incorporated boost in patients with early-stage breast cancer
Secondary
Determine the long-term cosmetic result and quality of life of patients treated with this regimen
Determine the long-term local control in patients treated with this regimen
OUTLINE Patients undergo adjuvant hypofractionated intensity-modulated radiotherapy with incorporated boost once daily 5 days a week for 4 weeks
Quality of life is assessed within 1 month of starting radiotherapy at 6 weeks after completion of radiotherapy and then every 6 months for 5 years
Patients are followed at 6 weeks and then every six months for 5 years
PROJECTED ACCRUAL A total of 37-74 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA006927 | NIH | None | None |
| 03026 | OTHER | Fox Chase Cancer Center | httpsreporternihgovquickSearchP30CA006927 |